Treatment of Antenatal Chlamydia Infection

Sponsor

Obafemi Awolowo University Teaching Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01946256

Collaborator

(none)

220

Enrollment

Location

Arms

Duration (Months)

44.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chlamydia Trachomatis Infection in Pregnancy	Drug: Amoxicillin Drug: Erythromycin	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

completion of course of medication and microbiological clearance [4 weeks after treatment]
The women will be screened 4 weeks after treatment to check for microbiological clearance

Secondary Outcome Measures

drug discontinuation rates [within 1 week of treatment]
The drug discontinuation rates between the two groups will be compared

Other Outcome Measures

occurrence of side effect. [1 week]
Occurrence of side effects will be considered between the two groups. The side effects include nausea, diarrhoea,vomiting and loss of appetite

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Test positive to Chlamydia rapid screening kit
Estimated gestational age less than 36 weeks
Consent to participate in the study
Willingness or ability to comply with follow-up schedule

Exclusion Criteria:

Antenatal patients whose gestational age is more than 36 weeks
History of reaction to any of the drugs
Women with low lying placenta or placenta Praevia
History of other antibiotics intake within two weeks of recruitment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife	Ile Ife	Imesi Ile	Nigeria	220001

Sponsors and Collaborators

Obafemi Awolowo University Teaching Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Okunola Temitope Omoladun, Erythromycin versus Amoxicillin for treatment of antenatal Chlamydia infection: a randomized controlled trial, Obafemi Awolowo University Teaching Hospital

ClinicalTrials.gov Identifier:

NCT01946256

Other Study ID Numbers: