Clinical Supply services: Phase 4 public health trial in clinically diagnosed neonatal sepsis (NeoSep1)


22 Oct 2021

GARDP Foundation (“GARDP”) is a not-for-profit organization developing new treatments for drug-resistant infections that pose the greatest threat to health. GARDP works with partners to ensure sustainable access to treatments, promoting responsible use and affordability to all in need. Created by the World Health Organization (WHO) and Drugs for Neglected Diseases initiative (“DNDi”), GARDP is essential to delivering on the Global Action Plan on Antimicrobial Resistance. GARDP’s goal is to partner with governments and treating physicians in low- and middle- income countries (LMIC) to bring fit for purpose solutions to the bedside of patients, that would save lives as well as promote the responsible use of antibiotics. GARDP operates with an international network of offices supporting the mission of GARDP including DNDi GARDP Southern Africa NPC and DNDi regional offices that carry out activities in support of the GARDP mission.

GARDP is sourcing a CRO able to supply clinical IMPs to the different sites of the following clinical trial; An open label randomized controlled trial to compare new and existing combination antibiotic regimens for treating clinically diagnosed neonatal sepsis (Part 2) with a run-in confirmatory pharmacokinetic phase (Part 1) to rank novel and existing combination antibiotic regimens for treating proven or suspected multidrug resistant neonatal sepsis. The full RFP is available here.

To nominate someone or self-nominate, please fill in the intent to participate letter and the Q&A form and e-mail it to gardpboard@gardp.org.

About GARDP

The Global Antibiotic Research and Development Partnership (GARDP) is a not-for-profit organization developing new treatments for drug-resistant infections that pose the greatest threat to health. GARDP was created by the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi) in 2016 to ensure that everyone who needs antibiotics receives effective and affordable treatment, no matter where they live. We aim to develop five new treatments by 2025 to fight drug-resistant infections, focusing on sexually transmitted infections, sepsis in newborns and infections in hospitalized adults and children. GARDP is funded by the governments of Germany, Luxembourg, Monaco, Netherlands, South Africa, Switzerland, United Kingdom, as well as Médécins Sans Frontières and private foundations. www.gardp.org


We use cookies to provide you a better experience and understand how our site is being used. To consent to the use of cookies, click ‘Accept’. Learn more about our cookie and privacy policy.