Treatment of Antenatal Chlamydia Infection

Obafemi Awolowo University Teaching Hospital

Status and phase: Completed; Phase 2

Conditions: Chlamydia Trachomatis Infection in Pregnancy

Treatments: Drug: Amoxicillin; Drug: Erythromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT01946256

ERC/2013/09/06

Details and patient eligibility

About

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 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

Enrollment: 220 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups, including a placebo group

Amoxicillin

Active Comparator group

Description:

Amoxicillin 500mg three times in a day for 1 week

Treatment:

Drug: Amoxicillin

Erythromycin

Placebo Comparator group

Description:

Erythromycin 500mg four times in a day for 1 week

Treatment:

Drug: Erythromycin