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Treatment of Antenatal Chlamydia Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Okunola Temitope Omoladun, Obafemi Awolowo University Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01946256
First received: September 16, 2013
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Chlamydia Trachomatis Infection in Pregnancy
Drug: Amoxicillin
Drug: Erythromycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Obafemi Awolowo University Teaching Hospital:

Primary Outcome Measures:
  • completion of course of medication and microbiological clearance [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]
    The women will be screened 4 weeks after treatment to check for microbiological clearance


Secondary Outcome Measures:
  • drug discontinuation rates [ Time Frame: within 1 week of treatment ] [ Designated as safety issue: No ]
    The drug discontinuation rates between the two groups will be compared


Other Outcome Measures:
  • occurrence of side effect. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Occurrence of side effects will be considered between the two groups. The side effects include nausea, diarrhoea,vomiting and loss of appetite


Enrollment: 220
Study Start Date: October 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946256

Locations
Nigeria
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
  More Information

Publications:
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     History of Changes
Other Study ID Numbers: ERC/2013/09/06
Study First Received: September 16, 2013
Last Updated: March 26, 2014
Health Authority: Nigeria: Federal Ministry of Health

Additional relevant MeSH terms:
Chlamydia Infections
Communicable Diseases
Infection
Bacterial Infections
Chlamydiaceae Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Amoxicillin
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014