NCT01904357 is a Phase 1 clinical trial of Cefazolin 1 GM Injection in Infections, sponsored by B. Braun Medical Inc..

Who is sponsoring NCT01904357?

NCT01904357 is sponsored by B. Braun Medical Inc..

What drugs are being tested in NCT01904357?

Interventions in NCT01904357: Cefazolin 1 GM Injection, Cefazolin 2 GM Injection.

What condition does NCT01904357 study?

NCT01904357 studies Infections.

Is NCT01904357 still recruiting?

NCT01904357 is currently completed. Last updated 20 July 2017.

Last reviewed 2017-07-20 · How we verify

NCT01904357

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

USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in Pediatric Subjects of 10-12 Years (Inclusive) Scheduled for Surgery

Completed Phase 1 Last updated 20 July 2017

What this trial tests

Phase 1 trial testing Cefazolin 1 GM Injection in Infections in 12 participants. Completed in 1 September 2013.

Timeline

1 March 2013

Primary endpoint
1 August 2013

1 September 2013

Quick facts

Lead sponsor	B. Braun Medical Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	12
Start date	1 March 2013
Primary completion	1 August 2013
Estimated completion	1 September 2013
Sites	2 locations across United States

Drugs / interventions tested

Cefazolin 1 GM Injection — full drug profile →
Cefazolin 2 GM Injection — full drug profile →

Conditions studied

Infections — all drugs for Infections →

Sponsor

B. Braun Medical Inc. — full company profile →

Who can join

Adults 10 to 12, any sex, with Infections. 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.

Single dose study to evaluate the pharmacokinetics of Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in pediatric subjects of 10-12 years (inclusive) scheduled for surgery
Time frame: 8 hours
To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.

Sponsor's own description

The primary objective of this study is: • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis. The secondary objectives of this study are: * To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with modeling data for adolescents aged 13-17 years (inclusive) and historical data from adults receiving a single 2g dose of cefazolin. * To assess the safety of a single dose of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Determination of appropriate weight-based cutoffs for empiric cefazolin dosing using data from a phase 1 pharmacokinetics and safety study of cefazolin administered for surgical prophylaxis in pediatric patients aged 10 to 12 years.
Schmitz ML, Blumer JL, Cetnarowski W, Rubino CM. · · 2015 · cited 9× · PMID 25941220 · DOI 10.1128/aac.00082-15

Verify or expand the search:

Other recruiting trials for Infections

Currently open trials in the same condition.

NCT07512141 — Single Versus Double Drains in the Axillary and Pectoral Regions After Modified Radical Mastectomy · NA · recruiting
NCT07189858 — Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections - Canada · NA · active not recruiting
NCT06426147 — L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients) · NA · recruiting
NCT06911658 — Infectious Complications After Esophagectomy · recruiting
NCT06145724 — EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 1) · NA · recruiting

Other B. Braun Medical Inc. trials

Trials by the same sponsor.

NCT05093244 — Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment · NA · withdrawn
NCT05205486 — Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults · Phase 1 · completed
NCT04048863 — Effect of B. Braun Peripheral Advantage Program on Complications, Indwell Time and First Stick Success of PIVC Therapy · NA · terminated
NCT03369756 — Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s) · NA · terminated
NCT03231228 — Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects · Phase 4 · terminated

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 NCT01904357 (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 B. Braun Medical Inc.
Last refreshed: 20 July 2017

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/NCT01904357.

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