Erythromycin Versus Amoxicillin for Treatment of Antenatal Chlamydia Trachomatis Infection: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- completion of course of medication and microbiological clearance
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Amoxicillin
Amoxicillin 500mg three times in a day for 1 week
干预措施: Amoxicillin (Drug)
Erythromycin
Erythromycin 500mg four times in a day for 1 week
干预措施: Erythromycin (Drug)
结局指标
主要结局
completion of course of medication and microbiological clearance
时间窗: 4 weeks after treatment
The women will be screened 4 weeks after treatment to check for microbiological clearance
次要结局
- drug discontinuation rates(within 1 week of treatment)
研究者
Okunola Temitope Omoladun
Erythromycin versus Amoxicillin for treatment of antenatal Chlamydia infection: a randomized controlled trial
Obafemi Awolowo University Teaching Hospital