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

NCT01503606 | Completed Phase 3

• 1 other identifier: 2011-07-005
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Premature Rupture of Membrane

Keywords

preterm premature rupture of membrane; antibiotics; duration; cefazolin; clarithromycin

Outcome Measures

Primary Outcomes (1)

• Neonatal composite morbidity

  1. respiratory distress syndrome(RDS) 2. bronchopulmonary dysplasia(BPD) 3. intraventricular hemorrhage(IVH,≥grade 3) 4. retinopathy of prematurity(ROP,≥grade 3) 5. necrotizing enterocolitis(NEC,≥stage 2) 6. proven neonatal sepsis

  Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks

Secondary Outcomes (1)

• infantile neurologic outcome

  at 6 months and 1 year of corrected age

Study Arms (2)

one-week treatment group

ACTIVE COMPARATOR

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week

Drug: Cefazolin; Drug: Clarithromycin

until-delivery treatment group

ACTIVE COMPARATOR

Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery

Drug: Cefazolin; Drug: Clarithromycin

Interventions

Cefazolin DRUG

Cefazolin 1.0gm IVs q 12 hours after randomization for one week

one-week treatment group

Clarithromycin DRUG

clarithromycin 500mg po bid after randomization for one week

one-week treatment group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Location

Related Publications (1)

• Sung JH, Kim JH, Kim Y, Choi YS, Hong S, Choi SJ, Kim JS, Roh CR, Oh SY. A randomized clinical trial of antibiotic treatment duration in preterm pre-labor rupture of membranes: 7 days vs until delivery. Am J Obstet Gynecol MFM. 2023 Apr;5(4):100886. doi: 10.1016/j.ajogmf.2023.100886. Epub 2023 Feb 4.

  PMID: 36746334 DERIVED

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Cefazolin; Clarithromycin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Soo-young Oh, MD, PhD

  Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 25, 2011
• First Posted: January 4, 2012
• Study Start: October 1, 2011
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

KR (1)