TITLE:
Rationale of Cross-Sectional Descriptive Study on Clinical Effectiveness of Oral Combination Therapy Based on Secnidazole, Azithromycin and Fluconazole in Syndromic Treatment of Abnormal Vaginal Discharge in Kinshasa/DR Congo
AUTHORS:
Muela Andy Mbangama, Feruzi Michel Mangala, Di-Mosi-Nkoyi Roger Wumba, Ambis Joelle Lumaya, Nkongolo Freddy Muamba, Mubalamata Eugene-Patrick Lukusa, Nkashama Bienvenu Kazadi, Ndombasi Nelda Lemba, Banza Jésual Lotoy, Oteme Christian Ndesanzim, Mwimba Roger Mbungu
KEYWORDS:
Combination Therapy, Syndromic Treatment, Abnormal Vaginal Discharge
JOURNAL NAME:
Open Journal of Obstetrics and Gynecology,
Vol.13 No.11,
November
16,
2023
ABSTRACT: Background: Vaginal discharge is one of the most common troubles faced by childbearing
age women. About 20% - 25% of women who visit service of gynecology complain of vaginal
discharge and leucorrhoea. Management of vaginal discharge in low-income
countries generally depends on syndromic approach, which limits the
understanding of specific responsible agents. Thus
targeted management is based on the identification of causal organism and
targeting of therapy against it, while syndromic management is based on
presence of high risk factors. Thus the
oral combination kit (Azimyn FS Kit®) offers convenience of a one-day treatment
compared to other multidose treatments, which will also ensure high patient
adherence to treatment, thus increasing chances of desired results. Due to its
widespread use, it is proposed to evaluate the effectiveness of this oral
association kit therapy in management of vaginal discharge in the population of
our milieu in the Democratic Republic of Congo (DRC) particularly those
received in outpatient consultation in some medical facilities in city of
Kinshasa. Expensive laboratory tests and the associated waiting period for result
mean that patient remains without treatment while waiting for test results.
Therefore, by adopting a syndromic management approach, patient’s eligibility
for treatment will be decided based on abnormal vaginal discharge, their
characteristics, severity and other presentations symptomatic. This approach
will also avoid losing sight of patients during
follow-up and will help to reduce financial burden for patients. Objectives: To determine the efficacy and safety of oral combination kit therapy
containing secnidazole, azithromycin and fluconazole (Azimyn FS Kit®) in
syndromic treatment of abnormal vaginal discharge in patients received in
outpatient consultation in some medical facilities in the city of Kinshasa; to
measure rate of recurrence of abnormal vaginal discharge in these patients. And
to identify the adverse effects observed in these patients who received
treatment with the combined oral kit containing secnidazole, azithromycin and
fluconazole (Azimyn FS Kit®) in outpatient consultation in some medical
facilities in the city of Kinshasa. Methods: It will be a cross-sectional descriptive study. Sample size will be 319 women
of childbearing age who consult the gynecology department with complaint of
abnormal vaginal discharge and suspicion of vaginal infection, who agree to
abstain from sex during treatment and who have given their written consent to
use their personal and/or health data in the study. Conclusion: A study on clinical efficacy of oral combination therapy based on
secnidazole, azithromycin and fluconazole is beneficial.