NCT00113191

A Phase III, Randomized, Double-blind, Multi-center Clinical Trial Comparing the Safety and Efficacy of Veronate® Versus Placebo for the Prevention of Nosocomial Staphylococcal Sepsis in Premature Infants (Birth Weight 500 - 1250 g)

Completed NA Last updated 26 July 2012

What this trial tests

NA trial testing Veronate in Nosocomial Infections in 2,000 participants. Completed in 1 June 2006.

Timeline

1 May 2004

Primary endpoint
1 June 2006

1 June 2006

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	prevention
Enrollment	2,000
Start date	1 May 2004
Primary completion	1 June 2006
Estimated completion	1 June 2006
Sites	93 locations across United States, Canada

Drugs / interventions tested

• Veronate — full drug profile →

Conditions studied

• Nosocomial Infections — all drugs for Nosocomial Infections →
• Sepsis — all drugs for Sepsis →
• Staphylococcal Infections — all drugs for Staphylococcal Infections →
• Candidemia — all drugs for Candidemia →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 3 Days to 5 Days, any sex, with Nosocomial Infections or Sepsis. 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.

• To assess the efficacy of Veronate® compared to placebo in preventing nosocomial S. aureus sepsis in premature infants
• To assess the safety profile of Veronate® compared to placebo in premature infants as measured by frequencies of adverse events, serious adverse events and morbidities associated with prematurity

Sponsor's own description

The purpose of this study is to show whether Veronate, a donor-selected staphylococcal human immune globulin intravenous (IGIV), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth.

Babies are enrolled between Day of Life 3 and 5. Babies are randomized to either Veronate or placebo (50-50 chance of either). Babies can receive up to 4 doses of the study drug on Study Days 1, 3, 8 and 15 and are followed until Study Day 70 or discharge from the hospital.

Publications & conference data

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

1. Fighting Staphylococcus aureus Biofilms with Monoclonal Antibodies.
   Raafat D, Otto M, Reppschläger K, Iqbal J, et al · · 2019 · cited 72× · PMID 30665698 · DOI 10.1016/j.tim.2018.12.009
2. Antibody-Based Immunotherapies as a Tool for Tackling Multidrug-Resistant Bacterial Infections.
   Seixas AMM, Sousa SA, Leitão JH. · · 2022 · cited 22× · PMID 36366297 · DOI 10.3390/vaccines10111789