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Evaluation of aetiological profiles, treatment appropriateness, and outcomes of syndromic management for reproductive tract infections in women from urban clinics
Corresponding author: Dr. Deepti Tandon, Department of Clinical Research, ICMR - National Institute for Research in Reproductive and Child Health, Parel, Mumbai, Maharashtra, India. gdeepti167@gmail.com
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Received: ,
Accepted: ,
How to cite this article: Tandon D, Ramachandra S, Kerkar SC, Begum S, Munne K, Patil AD, et al. Evaluation of aetiological profiles, treatment appropriateness, and outcomes of syndromic management for reproductive tract infections in women from urban clinics. Indian J Dermatol Venereol Leprol. 2026;92:164-70. doi: 10.25259/IJDVL_355_2025
Abstract
Background
While syndromic management is widely used in low-resource settings due to its cost-effectiveness and ease of patient care, growing concerns of antimicrobial resistance (AMR) and potential overtreatment highlight the need for regular aetiological testing to monitor treatment appropriateness.
Aim
To evaluate and compare syndromic management for reproductive tract infection for assessing treatment strategies.
Methods
In a prospective study, 250 sexually active, non-pregnant women aged 18–50 years, presenting with symptoms of lower genital tract infections were recruited as part of a prospective study from urban clinics in Mumbai. Participants underwent clinical and gynaecological examination, and standard syndromic management was provided. Samples were collected prior to treatment for Nugent scoring, Candida culture, and multiplex polymerase chain reaction (PCR) to detect sexually transmitted infections (STIs).
Results
The mean age of participants was 32.5 ± 6.6 years, with 51.2% (n=128) belonging to the upper-lower socioeconomic class. Vaginal discharge was the most common symptom (42%, n=105). Aetiological analysis identified causative agents in 90% (n=225) of cases, while 10% (n=25) showed no identifiable aetiology. The most prevalent pathogens were Ureaplasma parvum (47.2%) and Candida species (44.4%), followed by those causing bacterial vaginosis (39.2%). Among Candida species, Candida albicans (47.1%) and Candida krusei (45.2%) were most common. In contrast, Chlamydia trachomatis (3.2%) and Mycoplasma genitalium (1.2%) were less prevalent, and Neisseria gonorrhoeae was not detected. Syndromic management led to overtreatment rates exceeding 96% for these low-prevalence pathogens, raising concerns about AMR.
Limitations
Since this study is bounded to urban community clinics, it limits the expansion to rural scene, and AMR tests were not conducted due to the fastidious nature of microbes in the study and implementation challenges in resource limiting settings.
Conclusion
Syndromic management remains feasible in resource-limited settings; however, its limitations in addressing low-prevalence pathogens emphasises the need for periodic aetiological testing to improve diagnostic accuracy and guide appropriate treatment.
Keywords
Antimicrobial resistance
aetiological testing
lower genital tract infections
overtreatment
sexually transmitted infection/reproductive tract infection (STI/RTI) syndromic management
Introduction
Sexually transmitted infections (STIs) and reproductive tract infections (RTIs) are key contributors to reproductive health complications in women. Persistent infections in the lower genital tract caused by various pathogens can trigger inflammation in the upper genital tract, leading to issues such as pelvic inflammatory disease, ectopic pregnancy, chronic pelvic pain, and infertility.1 The World Health Organisation (WHO) Global Health Sector Strategy on Sexually Transmitted Infections (2016–2021), approved by the World Health Assembly in 2016, set a goal to eliminate STIs as a public health threat by 2030 (WHO guidelines, accessed in 2024).2 WHO recommends use of syndromic management since 1984, especially in low resource settings under which treatment is given based on the signs and symptoms presented by patients (WHO guidelines/training module, accessed in 2024).3 Though syndromic management remains a keystone for treating STI/RTI and saves time, cost, and resources, the indiscriminate use of antibiotics can lead to overtreatment and contribute to the development of antibiotic resistance.4 Neisseria gonorrhea and Mycoplasma genitalium are organisms reported to develop resistance to antibiotics, necessitating ongoing evolution in their treatment across the globe.5,6 Thus, periodic aetiological testing and monitoring treatment responses is essential to review existing treatment protocols, detect overtreatment, guide effective management, and assess the risk of contributing to antimicrobial resistance (AMR).
Methods
Ethics statement and recruitment
Ethical approval for this study was obtained from the Institutional ethics committee of Human Studies at Indian Council of Medical Research - National Institute for Research in Reproductive and Child Health (ICMR NIRRCH) and Institutional ethics committee of Seth GS Medical College and King Edward Memorial (KEM) Hospital, Mumbai (D/ICEC/Sci-229/242/2023). Informed consent was obtained and 250 healthy, sexually active, non-pregnant women aged 18 to 45 years, presenting with lower genital tract infections (LGTI), were recruited as a part of this ongoing longitudinal prospective study. The vaginal samples for the study were collected from March 2023 to September 2024 at the institute’s family welfare clinics and a collaborative hospital, all located in close proximity in an urban community of Mumbai. Asymptomatic women and women who had taken any antibiotics or antifungals in the last four weeks were excluded from the study, while women who were menstruating at the time of examination, were asked to return after five days for inclusion.
Recruitment and sample collection
All the patients recruited in the study were symptomatic for LGTI. The clinical symptoms of bacterial vaginosis, candida infection and other STIs are similar and overlap. Sociodemographic, contraceptive, menstrual, obstetric, sexual, and medical histories were recorded, followed by general physical and gynaecological examination. The sociodemographic profile was assessed using the Modified Kuppuswamy scale.7 Symptoms of lower genital tract infection such as itching, vaginal discharge, urinary complaints, and pain in the lower abdomen were recorded. Women were screened by per vaginal examination and cervico-vaginal swabs were collected at baseline (at the time of recruitment) on a glass slide for Gram stain to evaluate Nugent score and identifying Candida.8 An additional vaginal swab was collected in phosphate buffered saline and cultured on HiCromeTM Candida differential agar for identification of Candida species and for multiplex PCR to detect STIs. Following this, syndromic management was given in the same sitting based on the symptoms.
Sample processing
Gram-stained smears were air-dried, heat-fixed, and assessed microscopically at 100x oil immersion to determine the Nugent score for diagnosis of bacterial vaginosis .9 Scores of 0–3 were negative, 4–6 intermediate, and ≥7 positive, based on Lactobacillus morphotypes, Gardnerella/Bacteroides morphotypes, and curved Gram-variable rods across 10–20 high-power fields. Additional parameters included the presence of clue cells, pus cells, budding yeast cells, and hyphae indicating Candida species. The diagnosis of cervicitis was supported by observing ≥30 WBCs per high-power field.
Candida species were identified on Candida differential agar by colony colour: C. albicans (creamy bluish-green), C. krusei (creamy pinkish/magenta pink), C. glabrata (creamy white), and C. tropicalis (dark bluish green).10 Co-infections were assessed using the Urethritis Plus multiplex real-time polymerase chain reaction kit (Fast-Track Diagnostics, Luxembourg) to detect seven STI/RTI pathogens, including N. gonorrhea, C. trachomatis, M. genitalium, T. vaginalis (TV), U. parvum, U. urealyticum and M. hominis.11,12 Vaginal swabs in phosphate buffered saline (PBS) underwent DNA extraction with the QIAamp DNA blood mini kit (Qiagen) following the manufacturer’s protocol. Extracted DNA was used as a template for multiplex polymerase chain reaction (PCR). Positive samples displayed a sigmoid fluorescence curve with appropriate cycle threshold (Ct) values, confirming detection.
Overall, a patient was deemed positive for aetiological testing if (i) Candida was identified either through culture or Gram stain, (ii) if bacterial vaginosis was diagnosed using the Nugent score, or if (iii) any pathogen was detected through multiplex real-time PCR.
Treatment
Participants were treated at the time of recruitment (at baseline), after the clinical examination, on the basis of symptoms/signs. Treatment was according to the National RTI/STI Treatment Guidelines (2014) and Maternal Health Guidelines (2014) by the Ministry of Health and Family Welfare, Government of India.13 As per the guidelines, vaginal discharge syndrome caused by T. vaginalis or bacterial vaginosis was treated with secnidazole 2 g orally (single dose) or metronidazole 400 mg twice daily for 7 days. Candida infections were managed with fluconazole 150 mg orally or clotrimazole 500 mg vaginal pessary present in Kit 2. Cervical discharge syndrome or cervicitis due to N. gonorrhea or C. trachomatis was treated with cefixime 400 mg orally (single dose) and azithromycin 1 g orally, present in Kit 1. Lower abdominal pain syndrome caused by N. gonorrhea, C. trachomatis, Mycoplasma, Gardnerella, or anaerobic bacteria was managed with cefixime 400 mg orally (single dose), metronidazole 400 mg twice daily for 14 days, and doxycycline 100 mg twice daily for 14 days present in Kit 6. Combination kits containing fluconazole 150 mg, azithromycin 1 g and secnidazole 2 g were used based on availability.
Patients were counselled and educated on safe sexual practices and the importance of completing the treatment, and were encouraged for correct and consistent use of condoms. All the patients were referred to the Integrated Testing and Counselling Center (ITCT) to provide comprehensive HIV counselling and testing services. The counselling was based on the STI/RTI case management designed by the National AIDS control organization (NACO).
Follow up
The response to treatment was assessed after 7 to 14 days (when the patients were not menstruating), followed by the course of treatment, only for those who were positive for Candida or bacterial vaginosis or both (according to Gram stain). Response was recorded by noting changes in participants’ repeat Nugent scores and by Candida culture. For those initially positive for bacterial vaginosis or Candida infection, a response was classified as “responded to treatment” if their Gram stain or culture results were negative following treatment. Conversely, a classification of “not responded” was given if Gram stain and culture results remained positive post-treatment.
Statistical analysis
Summary statistics for quantitative variables and qualitative variables were presented as mean±SD and percent, respectively.
Results
Sociodemographic characteristics
A total of 250 women, with a mean age of 32.5 ± 6.6 years, were recruited for the study. Based on the Kuppuswamy socioeconomic scale, 51.2% (n=128) belonged to the upper-lower class, 22.4% (n=56) to the lower-middle class, and 25.6% (n=64) of participants belonged to the upper-middle, lower, or upper socioeconomic classes. Most participants (56.8%, n=142) had private toilets, while 39.2% (n=98) used common toilets, and 4% (n=10) relied on public toilets. The median coital frequency per month was four times (1–30), and all reported a single sexual partner in the past six months. Parity distribution showed 19.2% (n=48) were nulliparous, 17.6% (n=44) had one child, and 61.6% (n=154) of participants had two or more children. Most participants, 225 (90%), had no addictions, while a small percentage reported smoking (n=2, 0.8%), alcohol use (n=6, 2.5%), and smokeless tobacco (n=15, 6%). Condoms were used by 26.4% (n=66) of participants, while others relied on tubal ligation, intrauterine devices, injectables, or no contraception. Association was sought between sociodemographic parameters and those with aetiological agent; however, none were significant as presented in Supplementary Table S1.
Spectrum of symptoms and aetiological testing profile
The most common complaint was vaginal discharge, observed in 42% (n=105) of participants. Additionally, 4% (n=10) reported vaginal itching alone, 51.6% (n=129) experienced vaginal discharge and itching, and 2.8% (n=7) had urinary complaints and pain in the abdomen. Additional urinary complaints were reported by 23.6% (n=59) of women, along with vaginal discharge or itching, while 12.4% (n=31) experienced lower abdominal pain in conjunction with vaginal discharge or itching. Table 1 represents the results of the aetiological testing profile based on Nugent score, Candida culture, and multiplex PCR testing.
| Aetiological agent | No. of patients with infection n(%) |
|---|---|
| No aetiological agent | 25 (10) |
| Single aetiological agent | 84 (33.6) |
| Dual aetiological agents | 77 (30.8) |
| Triple or more aetiological agents | 64 (25.6) |
| Prevalence of various aetiological agents | |
| Chlamydia trachomatis (CT) | 8 (3.2) |
| Neisseria gonorrhoea (NG) | 0 |
| Mycoplasma genitalium (MG) | 3 (1.2) |
| Mycoplasma hominis (MH) | 60 (24) |
| Trichomonas vaginalis (TV) | 28 (11.2) |
| Ureaplasma urealyticum (UU) | 32 (12.8) |
| Ureaplasma parvum (UP) | 118 (47.2) |
| Bacterial vaginosis (BV) | 98 (39.2) |
| Candida spp.(Culture or Gram stain or both) | 111 (44.4) |
Based on Gram staining, culture, and multiplex testing, aetiology was identified in 225 (90%) cases, while 25 (10%) cases showed no identifiable cause [Figure 1a]. All patients received syndromic management. The most prevalent agents were U. parvum (47.2%) (among STIs), Candida (44.4%), and bacterial vaginosis (39.2%) [Figure 1b], In contrast, C. trachomatis, M. genitalium, and N. gonorrhea were less prevalent, at only 3.2%, 1.2%, and 0%, respectively [Figure 1c]. Further analysis of the aetiological profile revealed that among the cases, 30 (12.5%) and 3 (1.2%) who had received antibiotics were found to have U. parvum and U. urealyticum as the sole pathogens, respectively. The remaining cases had multiple pathogens. Only 1 (0.4%) patient had both C. trachomatis and M. genitalium.
- Prevalence of aetiologies in the study cohort, (a) Illustrates the no. of patients (%) with single, dual and multiple aetiology and without aetiology, (b) Prevalence of different aetiologies among the cohort, (c) Depicts the no. of patients (%) infected with different STIs (d) Prevalence of different species of Candida. (STI: Sexually transmitted infection)
Amongst 111 Candida detected, 7 (6.3%) were by Gram stain alone, 68 (61.2%) were by culture alone, and 36 (32.4%) were detected by both Gram stain and culture. The most common species of Candida in culture out of 104 detected were in the order of prevalence: C. albicans (n=49, 47.1%) and non-albicans, which include C. krusie (n=47, 45.2%), C. glabrata (n=13, 12.5%), C. tropicalis (n=3, 2.8%), and mixed species (n=18, 17.3%) [Figure 1d].
Utilisation of syndromic management kits for treatment of RTIs
The syndromic management of RTIs in the study population utilised specific treatment kits based on the presenting syndrome. Out of the total, 53 (21.2%) participants received both Kit 1 (azithromycin 1 g + cefixime 400 mg each single dose) and Kit 2 (secnidazole 2 g twice daily + fluconazole 150 mg single dose), addressing coexisting cervical discharge syndrome and vaginitis.
For cervical discharge syndrome, Kit 1 (azithromycin 1 g + cefixime 400 mg each single dose) or a combination kit was administered to 5 (2%) to address common STIs, such as C. trachomatis and N. gonorrhea. For vaginitis, most cases, 168 (67.2%), were treated with Kit 2 (secnidazole 2 g BID dose + fluconazole 150 mg single dose), targeting bacterial vaginosis and fungal infections. An additional 18 received kit 6 (cefixime 400 mg single dose + metronidazole 400 mg + doxycycline 100 mg, both BID dose for 14 days) and 6 received combination kits having clindamycin and clotrimazole. Therefore, 75 patients received antibiotics targeted towards C. trachomatis, N. gonorrhea, and M. genitalium, which were cervicitis causing organisms and 245 received antibiotics targeted towards bacterial vaginosis, T. vaginalis, Candida, U. parvum, U. urealyticum, and M. hominis, which were vaginal discharge syndrome causing organisms.
Comparison of treatment appropriateness based on aetiological findings and syndromic management
Among 250 patients, 75 received kit 1 and 245 received kit 2. Thereby, some patients received both the kits (Kit 1 and Kit 2) as treatment. Table 2 shows that overall, overtreatment with any syndromic management was 10%. However, when compared with specific aetiologies like C. trachomatis, N. gonorrhea, and M. genitalium, which were less prevalent and are linked to cervicitis, overtreatment was higher up to 96.1% with syndrome-specific kits and 95.9% with other syndromic kits. For infections/pathogens that were more prevalent like bacterial vaginosis, Candida, M. hominis, U. urealyticum and U. parvum, the overtreatment ranged from 10.6 % to 12.2%, with specific syndromic kits.
| Treatment | No. of patients with aetiology and treated n (%) (treated) | No. of patients without aetiology but treated n (%) (overtreated) |
|---|---|---|
| Any syndromic kit (n=250) | Any aetiology detected = 225 (90%) | No aetiology detected =25 (10%) |
| Organisms specific to cervicitis (CT/NG/MG) | ||
| Syndromic kits received by patients | Aetiology specific to cervicitis detected and treated = 10 | Aetiology specific to cervicitis not detected but treated = 240 |
| Syndromic kit specific to cervicitis (n=75) | 3 (4%) | 72 (96%) |
| Syndromic kit specific to vaginal discharge syndrome (n=245) | 10 (4.1%) | 235 (95.9%) |
| Organisms specific to vaginal discharge syndrome (BV/TV/CANDIDA/UP/UU/MH) | ||
| Syndromic kits received by patients | Aetiology specific to vaginal discharge syndrome detected and treated = 216 | Aetiology specific to vaginal discharge syndrome not detected but treated = 34 |
| Syndromic kit specific to cervicitis (n=75) | 67 (89.3%) | 8 (10.6%) |
| Syndromic kit specific to vaginal discharge syndrome (n=245) | 215 (87.8%) | 30 (12.2%) |
CT: Chlamydia tracomatis, NG: Neisseria gonorrhea, MG: Mycoplasma genitalium, BV: Bacterial vaginosis, TV: Trichomonas vaginalis, UP: Ureaplasma parvum, UU: Ureaplasma urealyticum, MH: Mycoplasma hominis
Response to treatment
Out of 250 women, 108 (43.2%) showed clinical improvement and symptomatic relief following syndromic management, while 58 (23.2%) continued to experience symptoms. A total of 84 women (33.6%) were either lost to follow-up or not required for follow-up as their initial Nugent score was normal. Among those with bacterial vaginosis (n=98), 49 (50%) responded to treatment, 37 (37.8%) did not respond, and 12 (12.2%) were lost to follow-up. Among participants with Candida spp. (n=120), 34 (28.3%) responded to treatment, 53 (44.6%) did not respond, and 33 (27.5%) were lost to follow-up.
Discussion
Syndromic management of RTIs was first recommended by the WHO in the 1990s as an approach in low- and middle-income settings, where aetiological diagnosis may not be feasible due to limited resources. This approach focuses on treating RTIs based on clinical syndromes rather than specific pathogens, which allows for immediate treatment without waiting for diagnostic confirmation, making it rapid and inexpensive.14 Existing guidelines endorsed by the World Health Assembly in 2016, with the aim to eliminate STIs as a public health threat by 2030, continue to recommend syndromic management where adequate diagnostic facilities are not available. WHO has also recommended using lab testing to support diagnosis and management.2
U. parvum, Candida, and bacterial vaginosis remain the most prevalent aetiological agents in women with respect to lower genital tract infections within this cohort. These findings are consistent with a 2019 study by Tandon et al., which also identified bacterial vaginosis and genital mycoplasmas as the primary contributors to infections and co-infections in women from a community clinic.8 There is a slight increase in the prevalence of C. trachomatis and M. genitalium compared to the earlier study, suggesting a gradual rise in these infections within the community clinic setting. However, N. gonorrhea remains undetectable in this population. Similar trends of decreasing prevalence have been reported in other community-based studies by Dubbink et al. (2018). The absence of N. gonorrhea and the relatively low detection rates of C. trachomatis and M. genitalium reflect regional variations.15,16,12 The high prevalence of bacterial vaginosis, Candida, and U. parvum aligns with findings from other studies showing the significant burden of non-STI-related infections in this population.
Recent studies show a shift in Candida infections, with non-albicans species like C. krusei, C. glabrata, and C. tropicalis becoming more common compared to C. albicans. Among Indian women, non-albicans species are now almost as prevalent as C. albicans. These non-albicans species are more likely to resist azole antifungal treatments, which are widely used. This highlights the need for regular monitoring and better treatment approaches to manage these infections effectively.17-19
This study highlights that there is very high overtreatment for less prevalent organisms like C. trachomatis, N. gonorrhea and M. genitalium. As evident in the literature, the potential to develop AMR is higher in these organisms, probably due to overtreatment. The overtreatment in more prevalent organisms is considerably less, and giving syndromic management in these patients without aetiological testing may still be worthwhile and cost-effective. As evident in the results, undertreatment is less as almost all women received antibiotics as part of the syndromic management. Both scenarios are problematic, as they contribute to the growing threat of AMR. In a study conducted by Chauhan et al. (2014) on 180 symptomatic women attending a tertiary care hospital in Gujarat, only 35.6% were found to have an identifiable aetiological agent, such as bacterial vaginosis, trichomoniasis, candidiasis, gonorrhoea, or chlamydia, highlighting that a majority of the women tested negative for these specific pathogens.20 Another study also assessed the effectiveness of syndromic management using kits in 11,000 women.21 However, PCR-based diagnostics revealed that 1,453 out of 1,797 (81%) women were uninfected with Neisseria gonorrhoeae, Trichomonas vaginalis, and Chlamydia trachomatis, thereby highlighting that the syndromic management is imprecise for detecting these infections—a concern that is also emphasised in the present study.21 Sonkar et al. in 2021 estimated that the overall rates of overuse and misuse of antibiotics were 92.87% and 8.69%, respectively, for infections like Chlamydia, Neisseria, and Trichomonas.22 The study proposed an alternative algorithm to the existing syndromic case management approach, suggesting that its implementation could potentially reduce the misuse and overuse of antibiotics from 92.87% to 23.82%.
The current guidelines and treatment approaches globally are evolving, with newer recommendations, such as the use of extended azithromycin for M. genitalium and cephalosporins for N. gonorrhea instead of quinolones, reflecting an ongoing shift toward pathogen-specific management where feasible.23 Gupta et al. (2019), has highlighted the need to frequently review syndromic management to evaluate its performance in the community.24 Hence, to improve patient care, there is a need for point-of-care diagnostic tools and affordable molecular testing, especially for the less prevalent organisms. It is required in Indian settings for routine clinical practice to improve the specificity of diagnosis and guide appropriate treatment in women presenting with vaginal infections.25,26
Another concern is the administration of antibiotics based on aetiological testing that identifies pathogens such as U. parvum and U. urealyticum in significant abundance. As highlighted by Tandon et al.8 (2022), these organisms are considered commensals, and their pathogenic potential remains uncertain. Therefore, the empirical use of antibiotics to target these organisms remains a subject of debate.
Limitations
This study is limited to urban clinics, restricting generalisability to rural settings. Antimicrobial susceptibility testing (AST) was not performed as it is usually limited to cultivable microbes. Further most sexually transmitted organisms require specialised culture techniques, and molecular AST for slow-growing pathogens, which is costly and demands skilled personnel, making implementation challenging in resource-limited settings. We collected the sample swabs from cervico-vaginal region as sensitive detection is possible with the same and it is a less invasive approach. However, endocervical swabs are preferred for some of the STI organisms detection.
Conclusion
Our study highlights that periodic aetiology testing should be recommended along with the syndromic management to guide existing clinical management strategies. While syndromic management offers a broad-spectrum approach, periodic aetiological profiling can help identify changes in pathogen prevalence and optimise treatment protocols. This can help in evolving treatment strategies and guiding policymakers. Periodic aetiologic testing specially for less prevalent organisms such as N. gonorrhea, C. trachomatis and M. genitalium should be included together with syndromic management. Furthermore, restricted use of azithromycin and cefixime is suggested to prevent overtreatment, thereby limiting the development of antimicrobial resistance.
Acknowledgement
We sincerely acknowledge support and guidance received from Dr. Geetanjali Sachdeva, Director, ICMR-NIRRCH. We humbly acknowledge the dedicated support of clinic staff—Mrs. Sunita Kharat, Mrs. Halima, Mrs. Shobha Banage, and Mrs. Sunita Kale.
Ethical approval
The research/study was approved by the Institutional Review Board at Indian Council of Medical Research – National Institute for Research in Reproductive and Child Health (ICMR NIRRCH) and Ethics Committee of Human Studies and Institutional ethics committee of Seth GS Medical College and King Edward Memorial (KEM) Hospital Mumbai, number D/ICEC/Sci-229/242/2023, dated 10th February 2023.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
The Indian Council of Medical Research Extramural grant (File no. 5/7/116/MH/Adhoc/2022-RBMCH)
Conflicts of interest
There are no conflicts of interest.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.
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