Treatment of Antenatal Chlamydia Infection
Primary Purpose
Chlamydia Trachomatis Infection in Pregnancy
Status
Completed
Phase
Phase 2
Locations
Nigeria
Study Type
Interventional
Intervention
Amoxicillin
Erythromycin
Sponsored by
About this trial
This is an interventional treatment trial for Chlamydia Trachomatis Infection in Pregnancy
Eligibility Criteria
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
Sites / Locations
- Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Amoxicillin
Erythromycin
Arm Description
Amoxicillin 500mg three times in a day for 1 week
Erythromycin 500mg four times in a day for 1 week
Outcomes
Primary Outcome Measures
completion of course of medication and microbiological clearance
The women will be screened 4 weeks after treatment to check for microbiological clearance
Secondary Outcome Measures
drug discontinuation rates
The drug discontinuation rates between the two groups will be compared
Full Information
NCT ID
NCT01946256
First Posted
September 16, 2013
Last Updated
March 26, 2014
Sponsor
Obafemi Awolowo University Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01946256
Brief Title
Treatment of Antenatal Chlamydia Infection
Official Title
Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Obafemi Awolowo University Teaching Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis Infection in Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amoxicillin
Arm Type
Active Comparator
Arm Description
Amoxicillin 500mg three times in a day for 1 week
Arm Title
Erythromycin
Arm Type
Placebo Comparator
Arm Description
Erythromycin 500mg four times in a day for 1 week
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Primary Outcome Measure Information:
Title
completion of course of medication and microbiological clearance
Description
The women will be screened 4 weeks after treatment to check for microbiological clearance
Time Frame
4 weeks after treatment
Secondary Outcome Measure Information:
Title
drug discontinuation rates
Description
The drug discontinuation rates between the two groups will be compared
Time Frame
within 1 week of treatment
Other Pre-specified Outcome Measures:
Title
occurrence of side effect.
Description
Occurrence of side effects will be considered between the two groups. The side effects include nausea, diarrhoea,vomiting and loss of appetite
Time Frame
1 week
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Temitope O Okunola, MB;BS
Organizational Affiliation
Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obafemi Awolowo University Teaching Hospitals Complex, Ile Ife
City
Ile Ife
State/Province
Imesi Ile
ZIP/Postal Code
220001
Country
Nigeria
12. IPD Sharing Statement
Citations:
PubMed Identifier
7968119
Citation
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.
Results Reference
background
Learn more about this trial
Treatment of Antenatal Chlamydia Infection
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