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Trial record 10 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries

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ClinicalTrials.gov Identifier: NCT03248297
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Alan Tita, University of Alabama at Birmingham

Brief Summary:
This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

Condition or disease Intervention/treatment Phase
Postpartum Sepsis Postpartum Endometritis Postpartum Fever Drug: Azithromycin Drug: Azithromycin and amoxicillin Drug: Placebo Phase 4

Detailed Description:
This 3-arm study is a large randomized clinical trial designed to evaluate the comparative effectiveness and safety of single dose oral azithromycin or combined azithromycin+amoxicillin compared to placebo for the prevention of peripartum infections and sepsis in laboring women. We have previously shown the effectiveness of azithromycin for extended spectrum antibiotic prophylaxis in addition to the standard cephalosporin alone for reduction of post-cesarean infections. In LICs, the fraction of maternal infection and sepsis from cesarean delivery is minimal. Therefore, it is necessary to evaluate strategies aimed at reducing these morbidities in women who have vaginal births. There is an increased risk of infection in women who have prolonged labor or prolonged rupture of membranes. Drawing from our findings with azithromycin-based extended antibiotic prophylaxis for cesarean delivery, we propose to adapt the intervention and evaluate a single oral dose of azithromycin (with or without oral amoxicillin) to prevent maternal peripartum infection and sepsis. This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥18 hours to 1 gram of oral azithromycin, 1 gram of azithromycin+2 grams of amoxicillin, compared to usual care (placebo). Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection and Sepsis in Laboring High-risk Women: 3-Arm RCT
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Azithromycin and amoxicillin placebo
Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.
Drug: Azithromycin
Azithromycin tablet

Drug: Placebo
Placebo tablet

Experimental: Azithromycin + amoxicillin
Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.
Drug: Azithromycin and amoxicillin
azithromycin and amoxicillin
Other Name: azithromycin, amoxicillin

Placebo Comparator: Usual Care
This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)
Drug: Placebo
Placebo tablet




Primary Outcome Measures :
  1. Peripartum infection [ Time Frame: Up to 6 weeks after delivery ]
    Maternal peripartum infection including chorioamnionitis, endometritis, wound infection, sepsis, deep infection, pneumonia or pyelonephritis


Secondary Outcome Measures :
  1. Newborn infection [ Time Frame: Up to 6 weeks after hospital discharge ]
    Newborn infection including sepsis, pneumonia, meningitis, urinary infection



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal delivery with

    1. Prolonged membrane rupture (≥8 hours) or
    2. Prolonged labor (≥18 hours).

Exclusion Criteria:

  • Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization: because standard antibiotic therapy for these conditions may confound trial intervention.
  • Allergy to azithromycin or amoxicillin
  • Plan for cesarean delivery prior to enrollment
  • Fetal demise or major congenital anomaly: Major congenital anomalies may confound assessment of neonatal outcomes and every attempt will be made up front to exclude them from randomization. However, some unrecognized fetal anomalies may inevitably be randomized. These will not be excluded post-randomization from the primary (maternal outcome) analysis; they will be taken into consideration in the secondary analyses of neonatal outcomes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248297


Contacts
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Contact: Akila Subramaniam, MD, MPH 205-934-5611 asubramaniam@uabmc.edu
Contact: Alan Tita, MD, PhD 205-934-5611 atita@uabmc.edu

Locations
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Cameroon
Cameroon Baptist Convention Health Services Recruiting
Bamenda, Cameroon
Contact: Pius Tih, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Alan Tita, MD, PhD University of Alabama at Birmingham

Publications of Results:
Other Publications:
WHO. WHO recommendations for prevention and treatment of maternal peripartum infections. Sept 2015 http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/peripartum-infections-guidelines/en/

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Responsible Party: Alan Tita, Professor and Director, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03248297     History of Changes
Other Study ID Numbers: CHI UAB MISP # 54628
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometritis
Anti-Bacterial Agents
Sepsis
Puerperal Infection
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Pregnancy Complications, Infectious
Pregnancy Complications
Puerperal Disorders
Amoxicillin
Anti-Infective Agents