Who is sponsoring NCT01503606?

NCT01503606 is sponsored by Samsung Medical Center.

What drugs are being tested in NCT01503606?

Interventions in NCT01503606: Cefazolin, Clarithromycin, Cefazolin, Clarithromycin.

What condition does NCT01503606 study?

NCT01503606 studies Preterm Premature Rupture of Membrane.

Is NCT01503606 still recruiting?

NCT01503606 is currently completed. Last updated 18 April 2022.

Last reviewed 2022-04-18 · How we verify

NCT01503606

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 18 April 2022

What this trial tests

Phase 3 trial testing Cefazolin in Preterm Premature Rupture of Membrane in 151 participants. Completed in 1 December 2021.

Timeline

1 October 2011

Primary endpoint
1 December 2020

1 December 2021

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	151
Start date	1 October 2011
Primary completion	1 December 2020
Estimated completion	1 December 2021
Sites	1 location across South Korea

Drugs / interventions tested

Cefazolin (CEFAZOLIN) — full drug profile →
Clarithromycin (clarithromycin) — full drug profile →
Cefazolin (CEFAZOLIN) — full drug profile →
Clarithromycin (clarithromycin) — full drug profile →

Conditions studied

Preterm Premature Rupture of Membrane — all drugs for Preterm Premature Rupture of Membrane →

Sponsor

Samsung Medical Center

Who can join

Eligibility, female only, with Preterm Premature Rupture of Membrane. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Neonatal composite morbidity
Time frame: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks
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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The Management of Pregnancy Complicated with the Previable Preterm and Preterm Premature Rupture of the Membranes: What about a Limit of Neonatal Viability?-A Review.
Feduniw S, Gaca Z, Malinowska O, Brunets W, et al · · 2022 · cited 8× · PMID 36010375 · DOI 10.3390/diagnostics12082025
A randomized clinical trial of antibiotic treatment duration in preterm pre-labor rupture of membranes: 7 days vs until delivery.
Sung JH, Kim JH, Kim Y, Choi YS, et al · · 2023 · cited 6× · PMID 36746334 · DOI 10.1016/j.ajogmf.2023.100886

Verify or expand the search:

Other trials of Cefazolin

Trials testing the same drug.

NCT06567808 — Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial · Phase 4 · not yet recruiting
NCT07478874 — Prophylaxis Against Surgical Site Infections Using Local as Well as Systemic Antibiotic · NA · completed
NCT07111702 — Prophylactic Antibiotics in Groin Hernioplasty · NA · completed
NCT05647993 — Comparing of Cefazolin Plus Azithromycin Versus Cefazolin in Prevention of Febrile Morbidity After Emergency Cesarean De · NA · completed
NCT05137119 — Staphylococcus Aureus Network Adaptive Platform Trial · Phase 4 · recruiting

Other recruiting trials for Preterm Premature Rupture of Membrane

Currently open trials in the same condition.

NCT06074601 — MIRACLE of LIFE Study · active not recruiting

Other Samsung Medical Center trials

Trials by the same sponsor.

NCT07482865 — Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support · NA · not yet recruiting
NCT07467213 — Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute M · Phase 4 · not yet recruiting
NCT07530913 — Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients · NA · enrolling by invitation
NCT07500701 — Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Pro · Phase 3 · recruiting
NCT07409441 — Korea Acute Myocardial Infarction Registry · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01503606 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Samsung Medical Center
Last refreshed: 18 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01503606.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing