Clinical trials to reduce health inequities in pregnant women, newborns and children – 2017

This call aims to accelerate the adaption and/or optimisation of treatment and prevention products (excluding vaccines) for PRDs in sub-Saharan Africa for use in pregnant women, newborns and/or children. Proposals were to focus on adaption of existing medicines, including off-patent products, to the specific needs of pregnant women, newborns and/or children.
Call identifier: RIA2017MC

ASAAP
Clinical evaluation of artesunate + amodiaquine + atovaquone – proguanil tri-therapy for malaria treatment in African children

Kwame Nkrumah University of Science and Technology (KNUST), Kumasi, Ghana with partners from Benin, Burkina Faso, France, Gabon, Germany, and Mali
Project coordinator: Dr. Oumou Maiga-Ascofare (KNUST), Ghana
Starting date: 01 March 2019
Duration: 48 months
EDCTP grant amount: EUR 7,642,364
Grant agreement: RIA2017MC-2022

BabyGel
A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea and pneumonia in Ugandan infants

University of Liverpool (UoL), Liverpool, United Kingdom with partners from Norway, Uganda, and United Kingdom
Project coordinator: Prof. Andrew Weeks (UoL), United Kingdom
Starting date: 01 February 2019
Duration: 60 months
EDCTP grant amount: EUR 5,977,299
Grant agreement: RIA2017MC-2029

EMPIRICAL
Empirical treatment against cytomegalovirus and tuberculosis in severe pneumonia in HIV-infected infants: a randomised controlled clinical trial

Servicio Madrileña de Salud (SERMAS), Madrid, Spain with partners from Côte d’Ivoire, France, Italy, Mozambique, the Netherlands, Spain, Uganda, United Kingdom, Zambia, and Zimbabwe
Project coordinator: Dr Pablo Rojo (Hospital 12 de Octubre /Complutense University), Madrid, Spain
Starting date: 01 February 2019
Duration: 60 months
EDCTP grant amount: EUR 7,680,619
Grant agreement: RIA2017MC-2013
Webnews: Lincoln Joins Major International HIV Trial

Neo bnAb
Effectiveness, efficacy and operational feasibility of passive transfer of VRC01-LS antibody to prevent intra-/postpartum HIV mother-to-child transmission during the breastfeeding period in HIV-exposed infants from Tanzania and Mozambique: a prospective, randomised, double-blind placebo-controlled proof-of-concept trial

Ludwig Maximilians Universität München (LMU), Munich, Germany with partners from Mozambique, Tanzania, and United Kingdom
Project coordinator: Dr Arne Kroidl (LMU, Munich, Germany)
Starting date: 01 May 2019
Duration: 60 months
EDCTP grant amount: EUR 4,237,276
Grant agreement: RIA2017MC-2021

PediCAP Trial
Impact of duration of antibiotic therapy and of oral step-down to amoxicillin or co-amoxiclav on effectiveness, safety and selection of antimicrobial resistance in severe and very severe childhood community-acquired pneumonia (CAP): a randomised controlled trial

Fondazione PENTA Onlus, Padua, Italy with partners from Belgium, South Africa, Switzerland, Uganda, United Kingdom, Zambia, and Zimbabwe
Project coordinator: Prof. Carlo Giaquinto (Fondazione PENTA Onlus, Italy)
Starting date: 01 April 2019
Duration: 60 months
EDCTP grant amount: EUR 6,997,078
Grant agreement: RIA2017MC-2023

PREGART
Safety and efficacy of dolutegravir and EFV400 for pregnant and breastfeeding women: a randomised non-inferiority clinical trial

Hawassa University, Addis Ababa, Ethiopia with partners from Italy, Sweden, and Uganda
Project coordinator: Dr Birkneh Tadesse, MD
Starting date: 01 June 2019
Duration: 60 months
EDCTP grant amount: EUR 3,902,469
Grant agreement: RIA2017MC-2009

PYRAPREG
Efficacy and safety of a newly registered artemisinin-based combination (pyronaridine-artesunate – Pyramax®) for the treatment of uncomplicated malaria in African pregnant women

Université des sciences, des techniques et des technologies de Bamako (USTTB), Bamako, Mali with partners from the Democratic Republic of the Congo, Mozambique, Netherlands, Spain, and the United Kingdom
Project coordinator: Dr Kassoum Kayentao
Starting date: 01 March 2019
Duration: 60 months
EDCTP grant amount: EUR 7,085,862
Grant agreement: RIA2017MC-2025