Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane

Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.

The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.

Study Overview

• Status: Completed
• Conditions: Preterm Premature Rupture of Membrane
• Intervention / Treatment: Drug: Cefazolin; Drug: Clarithromycin; Drug: Cefazolin; Drug: Clarithromycin

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center, Sungkyunkwan University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• preterm premature rupture of membrane(PPROM), PA 22+0~34+0wks
• ROM <72 hrs before randomization
• cervical dilatation <3cm
• uterine contraction less than 4 times per 1 hr

Exclusion Criteria:

• Major fetal malformation
• Rupture of the membrane >72hrs before randomization
• Vaginal bleeding
• IIOC (incompetent internal os of cervix)
• Placenta previa
• Gestational diabetes or overt diabetes
• Hypertensive disorders in pregnancy
• Liver cirrhosis
• Acute renal failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: one-week treatment group; Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week	Drug: Cefazolin; Cefazolin 1.0gm IVs q 12 hours after randomization for one week; Drug: Clarithromycin; clarithromycin 500mg po bid after randomization for one week; Drug: Cefazolin; Cefazolin 1.0gm IVs q 12 hours after randomization until delivery; Drug: Clarithromycin; clarithromycin 500mg po bid after randomization until delivery
Active Comparator: until-delivery treatment group; Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery	Drug: Cefazolin; Cefazolin 1.0gm IVs q 12 hours after randomization for one week; Drug: Clarithromycin; clarithromycin 500mg po bid after randomization for one week; Drug: Cefazolin; Cefazolin 1.0gm IVs q 12 hours after randomization until delivery; Drug: Clarithromycin; clarithromycin 500mg po bid after randomization until delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal composite morbidity	respiratory distress syndrome(RDS); bronchopulmonary dysplasia(BPD); intraventricular hemorrhage(IVH,≥grade 3); retinopathy of prematurity(ROP,≥grade 3); necrotizing enterocolitis(NEC,≥stage 2); proven neonatal sepsis	Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infantile neurologic outcome	The outcome will be evaluated in five sub-domains (development, neurologic examination, Bayley Scales of Infant Development-II, vision, and hearing). The final outcome scale was divided into normal, mild, moderate, and severe disability	at 6 months and 1 year of corrected age

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Soo-young Oh, MD, PhD, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: December 25, 2011
• First Submitted That Met QC Criteria: January 1, 2012
• First Posted (Estimate): January 4, 2012

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: antibiotics; clarithromycin; duration; cefazolin; preterm premature rupture of membrane
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin; Cefazolin
• Other Study ID Numbers: 2011-07-005