Trial Outcomes & Findings for Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries (NCT NCT03248297)

NCT ID: NCT03248297

Last Updated: 2022-07-18

Results Overview

Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 756 participants
• Primary outcome timeframe: Up to 6 weeks after delivery
• Results posted on: 2022-07-18

Participant Flow

Participant milestones

Measure	Azithromycin and Amoxicillin Placebo Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	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) Placebo: Placebo tablet
Overall Study STARTED	253	253	250
Overall Study COMPLETED	253	253	250
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet	Total n=756 Participants Total of all reporting groups
Age, Customized	27.2 years STANDARD_DEVIATION 5.3 • n=5 Participants	26.4 years STANDARD_DEVIATION 5.6 • n=7 Participants	26.0 years STANDARD_DEVIATION 5.3 • n=5 Participants	26.5 years STANDARD_DEVIATION 5.4 • n=4 Participants
Sex: Female, Male Female	253 Participants n=5 Participants	253 Participants n=7 Participants	250 Participants n=5 Participants	756 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	253 Participants n=5 Participants	253 Participants n=7 Participants	250 Participants n=5 Participants	756 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	253 Participants n=5 Participants	253 Participants n=7 Participants	250 Participants n=5 Participants	756 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Gestational age at Randomization	39.4 Weeks STANDARD_DEVIATION 1.5 • n=5 Participants	39.2 Weeks STANDARD_DEVIATION 1.4 • n=7 Participants	39.2 Weeks STANDARD_DEVIATION 1.4 • n=5 Participants	39.3 Weeks STANDARD_DEVIATION 1.4 • n=4 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks after delivery

Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced Composite Peripartum Infection or Death	15 Participants	17 Participants	24 Participants

SECONDARY outcome

Timeframe: Up to hospital discharge

Other Infections

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced Pyelonephritis	2 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 6 weeks after delivery

Other infections

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced Breast Infection	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 6 weeks after delivery

Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced Other Infection	4 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 6 weeks after delivery

Any fever higher than 38C

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced Fever	22 Participants	21 Participants	28 Participants

SECONDARY outcome

Timeframe: up to 6 weeks after delivery

Any hypothermia less than 36C

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced Hypothermia	9 Participants	11 Participants	15 Participants

SECONDARY outcome

Timeframe: up to 6 weeks after delivery

Any postpartum antibiotic

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Needed PP Antibiotic	18 Participants	18 Participants	26 Participants

SECONDARY outcome

Timeframe: up to 6 weeks after delivery

Blood transfusion

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced Transfusion	8 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: delivery

Any stillbirth

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced Stillbirth	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 6 weeks postpartum

Length of stay in days

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Length of Stay	3.7 days Standard Deviation 2.0	3.7 days Standard Deviation 2.2	3.8 days Standard Deviation 3.1

SECONDARY outcome

Timeframe: up to 6 weeks after delivery

Clinic visit after discharge

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced a Clinic Visit	13 Participants	7 Participants	10 Participants

SECONDARY outcome

Timeframe: up to 6 weeks after delivery

Maternal readmission

Outcome measures

Measure	Azithromycin and Amoxicillin Placebo n=253 Participants Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet	Azithromycin + Amoxicillin n=253 Participants Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin	Usual Care n=250 Participants 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) Placebo: Placebo tablet
Number of Participants Who Experienced a Maternal Readmission	11 Participants	4 Participants	5 Participants

Adverse Events

Azithromycin and Amoxicillin Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Azithromycin + Amoxicillin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alan Tita, MD

University of Alabama at Birmingham

Phone: 205-934-5612

Email: atita@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place