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Treatment of ppROM With Erythromycin vs. Azithromycin Trial (TREAT)

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ClinicalTrials.gov Identifier: NCT03060473
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This pregnancy complication is a major contributor to preterm births and results in neonatal morbidity and mortality. The current standard of care for PPROM subjects between the gestational age of 24 weeks and 0 days and 33 weeks and 6 days, is to administer ampicillin and erythromycin for a total of 7 days. Erythromycin can cause GI upset and some subjects do not tolerate this regimen over the course of 7 days. In addition, there is a national shortage of erythromycin, and published expert opinion proposed to use a second-generation macrolide (azithromycin) instead of erythromycin. Azithromycin can be taken once daily, is cheaper than erythromycin and has less GI upset adverse effects. The investigators' objective is to compare the effectiveness of the 2 regimens in prolonging pregnancy after PPROM. The investigators' working hypothesis is that there is no measurable difference in the primary outcome between the group randomized to the azithromycin regimen versus the group randomized to the erythromycin regimen.

Condition or disease Intervention/treatment Phase
Preterm Premature Rupture of Membranes (PPROM) Drug: Azithromycin Drug: Erythromycin Drug: Ampicillin Drug: Amoxicillin Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Allocation: Randomized Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single Blind
Primary Purpose: Treatment
Official Title: TREAT: Treatment of ppROM With Erythromycin vs. Azithromycin Trial
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
Experimental: Azithromycin
Ampicillin 2 gm IV every 6 hours followed by amoxicillin 500 mg PO every 8 hours with Azithromycin 1 gm PO once at randomization.
Drug: Azithromycin
Azithromycin 1 gm PO once

Drug: Ampicillin
Ampicillin 2 gm IV every 6 hours for 2 days

Drug: Amoxicillin
Amoxicillin 500 mg PO every 8 hours for 5 days

Active Comparator: Erythromycin
Ampicillin 2 gm IV every 6 hours followed by amoxicillin 250 mg PO every 8 hours for 5 days with erythromycin 250 mg IV every 6 hours for 48 hours followed by 500 mg PO every 8 hours for 5 days.
Drug: Erythromycin
Erythromycin 250 mg IV every 6 hours for 48 hours followed by 500 mg PO every 8 hours for 5 days.

Drug: Ampicillin
Ampicillin 2 gm IV every 6 hours for 2 days

Drug: Amoxicillin
Amoxicillin 500 mg PO every 8 hours for 5 days




Primary Outcome Measures :
  1. Proportion of women still pregnant by day 7 [ Time Frame: 7 days ]
    Proportion of women still pregnant by day 7 after the diagnosis of PPROM is made. The investigators' working hypothesis is that there is no measurable difference in the primary outcome between the group randomized to the azithromycin regimen versus the group randomized to the erythromycin regimen


Secondary Outcome Measures :
  1. Latency defined as interval from PPROM to delivery. [ Time Frame: 7 days ]
    Number of days from diagnosis of PPROM to delivery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study is to be carried out on pregnant patients with diagnosis of PPROM.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Maternal age ≥ 18 years and <50 years
  • Pregnant women between the gestational age 23 6/7 and 32 6/7 weeks
  • Singleton pregnancy
  • Preterm premature rupture of membranes, determined clinically
  • Cervical dilation visually ≤ 5cm on sterile speculum exam.
  • Planned delivery at John Sealy Hospital (JSH)

Exclusion Criteria:

  • Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians)
  • Any contraindication to expectant management (e.g. fetal compromise, chorioamnionitis, placental abruption)
  • Cervical cerclage in place
  • Placenta previa or other known placental anomalies
  • Contraindication to any of the antibiotics used (allergy to macrolides).
  • Enrolled in another trial that may affect outcome.
  • 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.
  • No prenatal care (less than 2 prenatal visits)
  • Non-resident subject who is unlikely to be followed-up after delivery
  • Any fetal congenital anomaly.
  • Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal
  • Significant renal disease defined as serum creatinine known to be >2.0 mg/dl or on dialysis.
  • Active congestive heart failure (EF<45%) or pulmonary edema.
  • Immunosuppressed subjects: i.e., taking systemic immunosuppressants or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4<200, or other.

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): NCT03060473


Contacts
Contact: Antonio F Saad, MD 8187311674 afsaad@utmb.edu
Contact: Fawzi Saoud, MD 4094579285 fasaoud@utmb.edu

Locations
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Tony S Wen, MD    281-460-5566    twen@umc.edu   
United States, Texas
St. David's North Austin Medical Center Recruiting
Austin, Texas, United States, 78758
Contact: Richard T Hale, PhD    512-821-2540    Richard.Hale@stdavids.com   
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Antonio F Saad, MD    818-731-1674    afsaad@utmb.edu   
Contact: Fawzi Saoud, MD    4094579285    fasaoud@utmb.edu   
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Antonio F Saad, MD Assistant Professor Maternal Fetal Medicine

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03060473     History of Changes
Other Study ID Numbers: 16-0323
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by The University of Texas Medical Branch, Galveston:
PPROM
Azithromycin
Erythromycin

Additional relevant MeSH terms:
Rupture
Fetal Membranes, Premature Rupture
Wounds and Injuries
Obstetric Labor Complications
Pregnancy Complications
Amoxicillin
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Ampicillin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action