Treatment of Antenatal Chlamydia Infection

Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Chlamydia Trachomatis Infection in Pregnancy
• Intervention / Treatment: Drug: Erythromycin; Drug: Amoxicillin

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

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Nigeria
  • Imesi Ile
    • Ile Ife, Imesi Ile, Nigeria, 220001
      • Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Amoxicillin; Amoxicillin 500mg three times in a day for 1 week	Drug: Amoxicillin
Placebo Comparator: Erythromycin; Erythromycin 500mg four times in a day for 1 week	Drug: Erythromycin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
drug discontinuation rates	The drug discontinuation rates between the two groups will be compared	within 1 week of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of side effect.	Occurrence of side effects will be considered between the two groups. The side effects include nausea, diarrhoea,vomiting and loss of appetite	1 week

Collaborators and Investigators

• Sponsor: Obafemi Awolowo University Teaching Hospital
• Investigators: Principal Investigator: Temitope O Okunola, MB;BS, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife

Publications and helpful links

General Publications

• 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. doi: 10.1016/s0140-6736(94)90288-7.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: September 16, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (Estimate): September 19, 2013

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 26, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Sexually Transmitted Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Chlamydiaceae Infections; Sexually Transmitted Diseases, Bacterial; Infections; Communicable Diseases; Chlamydia Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Amoxicillin
• Other Study ID Numbers: ERC/2013/09/06