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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin and amoxicillin placebo | Experimental | Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. |
|
| Azithromycin + amoxicillin | Experimental | Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. |
|
| Usual Care | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Azithromycin tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Composite Peripartum Infection or Death | Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death | Up to 6 weeks after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Pyelonephritis | Other Infections | Up to hospital discharge |
| Number of Participants Who Experienced Breast Infection | Other infections |
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Inclusion Criteria:
Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal delivery with
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Tita, MD, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cameroon Baptist Convention Health Services | Bamenda | Cameroon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10196487 | Background | Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96. | |
| 10511234 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Azithromycin + Amoxicillin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced Composite Peripartum Infection or Death | Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death | Posted | Count of Participants | Participants | Up to 6 weeks after delivery |
|
up to 6 weeks after delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Tita, MD | University of Alabama at Birmingham | 205-934-5612 | atita@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2018 | Nov 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011645 | Puerperal Infection |
| ID | Term |
|---|---|
| D011251 | Pregnancy Complications, Infectious |
| D007239 | Infections |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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Randomized Controlled Trial
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| Azithromycin and amoxicillin |
| Drug |
azithromycin and amoxicillin |
|
|
| Placebo | Drug | Placebo tablet |
|
| Up to 6 weeks after delivery |
| Number of Participants Who Experienced Other Infection | Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria | up to 6 weeks after delivery |
| Number of Participants Who Experienced Fever | Any fever higher than 38C | up to 6 weeks after delivery |
| Number of Participants Who Experienced Hypothermia | Any hypothermia less than 36C | up to 6 weeks after delivery |
| Number of Participants Who Needed PP Antibiotic | Any postpartum antibiotic | up to 6 weeks after delivery |
| Number of Participants Who Experienced Transfusion | Blood transfusion | up to 6 weeks after delivery |
| Number of Participants Who Experienced Stillbirth | Any stillbirth | delivery |
| Length of Stay | Length of stay in days | up to 6 weeks postpartum |
| Number of Participants Who Experienced a Clinic Visit | Clinic visit after discharge | up to 6 weeks after delivery |
| Number of Participants Who Experienced a Maternal Readmission | Maternal readmission | up to 6 weeks after delivery |
| ASHP Therapeutic Guidelines on Antimicrobial Prophylaxis in Surgery. American Society of Health-System Pharmacists. Am J Health Syst Pharm. 1999 Sep 15;56(18):1839-88. doi: 10.1093/ajhp/56.18.1839. No abstract available. |
| 28076707 | Background | Tita ATN, Boggess K, Saade G. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2017 Jan 12;376(2):182. doi: 10.1056/NEJMc1614626. No abstract available. |
| Background | 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/ |
| 34619734 | Derived | Subramaniam A, Ye Y, Mbah R, Mbunwe DM, Pekwarake S, Bunwi EY, Fondzeyuf A, Ngong MG, Dionne-Odom J, Harper LM, Jauk VC, Carlo WA, Halle-Ekane G, Szychowski JM, Tih P, Tita AT. Single Dose of Oral Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection in Laboring, High-Risk Women in Cameroon: A Randomized Controlled Trial. Obstet Gynecol. 2021 Nov 1;138(5):703-713. doi: 10.1097/AOG.0000000000004565. |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gestational age at Randomization | Mean | Standard Deviation | Weeks |
|
| OG002 | 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 |
|
|
| Secondary | Number of Participants Who Experienced Pyelonephritis | Other Infections | Posted | Count of Participants | Participants | Up to hospital discharge |
|
|
|
| Secondary | Number of Participants Who Experienced Breast Infection | Other infections | Posted | Count of Participants | Participants | Up to 6 weeks after delivery |
|
|
|
| Secondary | Number of Participants Who Experienced Other Infection | Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria | Posted | Count of Participants | Participants | up to 6 weeks after delivery |
|
|
|
| Secondary | Number of Participants Who Experienced Fever | Any fever higher than 38C | Posted | Count of Participants | Participants | up to 6 weeks after delivery |
|
|
|
| Secondary | Number of Participants Who Experienced Hypothermia | Any hypothermia less than 36C | Posted | Count of Participants | Participants | up to 6 weeks after delivery |
|
|
|
| Secondary | Number of Participants Who Needed PP Antibiotic | Any postpartum antibiotic | Posted | Count of Participants | Participants | up to 6 weeks after delivery |
|
|
|
| Secondary | Number of Participants Who Experienced Transfusion | Blood transfusion | Posted | Count of Participants | Participants | up to 6 weeks after delivery |
|
|
|
| Secondary | Number of Participants Who Experienced Stillbirth | Any stillbirth | Posted | Count of Participants | Participants | delivery |
|
|
|
| Secondary | Length of Stay | Length of stay in days | Posted | Mean | Standard Deviation | days | up to 6 weeks postpartum |
|
|
|
| Secondary | Number of Participants Who Experienced a Clinic Visit | Clinic visit after discharge | Posted | Count of Participants | Participants | up to 6 weeks after delivery |
|
|
|
| Secondary | Number of Participants Who Experienced a Maternal Readmission | Maternal readmission | Posted | Count of Participants | Participants | up to 6 weeks after delivery |
|
|
|
| 0 |
| 253 |
| 0 |
| 253 |
| 0 |
| 253 |
| EG001 | 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 | 0 | 253 | 0 | 253 | 0 | 253 |
| EG002 | 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 | 0 | 250 | 0 | 250 | 0 | 250 |
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| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| Organic Chemicals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |