Treatment of Antenatal Chlamydia Infection

Overview

PREGNANT WOMEN IN ANTENATAL CLINIC WILL BE SCREENED FOR CHLAMYDIA TRACHOMATIS INFECTION WITH ENDOCERVICAL SWAB.THOSE THAT TEST POSITIVE AND SATISFY THE INCLUSION CRITERIA WILL BE COUNSELLED AND ENROLLED INTO THE STUDY AFTER OBTAINING INFORMED CONSENT.THE PARTICIPANTS WILL BE RANDOMISED INTO ONE OF THE TWO GROUPS.THE DRUGS WILL BE TAKEN FOR I WEEK AND THE SEXUAL PARTNER(S) WILL ALSO BE TREATED WITH DOXYCYCLINE FOR 1 WEEK. BARRIER CONTRACEPTION WILL ALSO BE USED DURING THE TREATMENT.THE SEXUAL PARTNERS WILL BE CONTACTED THROUGH TELEPHONE CALLS AND THE BENEFITS OF PARTICIPATING IN THE STUDY WILL BE EXPLAINED TO THEM. LATEX MALE CONDOM WILL BE GIVEN TO THE WOMEN. ALSO, FOLLOW-UP TELEPHONE CALLS WILL BE PUT ACROSS TO THEM DURING THE TREATMENT WEEK TO ENHANCE COMPLIANCE. A REPEAT ENDOCERVICAL SWAB WILL BE TAKEN 4 WEEKS AFTER TREATMENT TO CHECK FOR MICROBIOLOGICAL CLEARANCE. A STUDY PROFORMA WILL BE FILLED DURING THIS VISIT. THE DATA WILL BE ANALYSED USING STATISTICAL PACKAGE FOR SOCIAL SCIENCES VERSION 17.

Full Title of Study: “Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

Detailed Description

AIM(S) OF THE RESEARCH TO ASSESS THE EFFICACY AND TOLERABILITY OF AMOXICILLIN COMPARED TO ERYTHROMYCIN IN TREATMENT OF ANTENATAL CHLAMYDIA INFECTION

OBJECTIVES OF THE RESEARCH

- TO DETERMINE THE PREVALENCE OF CHLAMYDIA TRACHOMATIS INFECTION IN PREGNANCY

- TO COMPARE THE PROPORTION OF SUBJECTS WITH CLEARANCE OF ANTENATAL CHLAMYDIA TRACHOMATIS INFECTION BETWEEN THE ERYTHROMYCIN AND AMOXICILLIN GROUPS

- TO COMPARE THE OCCURENCE OF SIDE EFFECTS BETWEEN THE TWO GROUPS

- TO COMPARE THE DRUG DISCONTINUATION RATES BETWEEN THE TWO GROUP

Interventions

  • Drug: Amoxicillin
  • Drug: Erythromycin

Arms, Groups and Cohorts

  • Active Comparator: Amoxicillin
    • Amoxicillin 500mg three times in a day for 1 week
  • Placebo Comparator: Erythromycin
    • Erythromycin 500mg four times in a day for 1 week

Clinical Trial Outcome Measures

Primary Measures

  • completion of course of medication and microbiological clearance
    • Time Frame: 4 weeks after treatment
    • The women will be screened 4 weeks after treatment to check for microbiological clearance

Secondary Measures

  • drug discontinuation rates
    • Time Frame: within 1 week of treatment
    • The drug discontinuation rates between the two groups will be compared

Participating in This Clinical Trial

Inclusion Criteria

1. Test positive to Chlamydia rapid screening kit

2. Estimated gestational age less than 36 weeks

3. Consent to participate in the study

4. Willingness or ability to comply with follow-up schedule

Exclusion Criteria

1. Antenatal patients whose gestational age is more than 36 weeks

2. History of reaction to any of the drugs

3. Women with low lying placenta or placenta Praevia

4. History of other antibiotics intake within two weeks of recruitment

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Obafemi Awolowo University Teaching Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Okunola Temitope Omoladun, Erythromycin versus Amoxicillin for treatment of antenatal Chlamydia infection: a randomized controlled trial – Obafemi Awolowo University Teaching Hospital
  • Overall Official(s)
    • Temitope O Okunola, MB;BS, Principal Investigator, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife

References

Alary M, Joly JR, Moutquin JM, Mondor M, Boucher M, Fortier A, Pinault JJ, Paris G, Carrier S, Chamberland H, et al. Randomised comparison of amoxycillin and erythromycin in treatment of genital chlamydial infection in pregnancy. Lancet. 1994 Nov 26;344(8935):1461-5.

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