Past trials

CVD-Mali has been involved in numerous clinical trials since its inception. You can read about a few of these below.

A B C D

The Antibiotics for Children with Severe Diarrhoea (ABCD) trial contributed to global attempts to reduce mortality rates in children as a result of acute diarrheal episodes. The study sought to evaluate the long-term benefits and effects of antibiotic administration and to optimize antibiotic treatment of acute diarrhoea episodes in very young children.

The antibiotic azithromycin was delivered in a specific, targeted fashion to young children (< 2 years of age) at high risk of diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled trial. The study evaluated the ability of the intervention to reduce mortality within 180 days of the acute diarrhoeal episode, and improve nutritional status over the first 90 days.

The study was concluded in January 2020 and the results will be published shortly.

Collaborators

International Centre for Diarrheal Disease Research, Bangladesh, Center for Public Health Kinetics, Kenya Medical Research Institute, University of Washington, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Liverpool, CVD-Mali, University of Maryland, Baltimore, College Park, Aga Khan University, Muhimbili University of Health and Allied Sciences, Boston Children’s Hospital

gems

The Global Enteric Multicenter Study (GEMS) was a three-year, prospective, age-stratified, case/control study to estimate the population-based burden, microbiologic etiology, and adverse clinical consequences of acute moderate-to-severe diarrhea (MSD) among a censused population of children aged 0-59 months seeking care at health centres in sub-Saharan Africa and South Asia.

CVD-Mali acted as the study’s Malian partner, in collaboration with the University of Maryland, Baltimore.

GEMS was conducted at seven field sites, each serving a population whose demography and healthcare utilization practices for childhood diarrhea were documented. Cases and controls supplied clinical, epidemiologic, and anthropometric data and analytic strategies were used to calculate the fraction of MSD attributable to each pathogen and the incidence, financial costs, nutritional consequences, and case fatality overall and by pathogen.

GEMS provided valuable estimates of the incidence, etiology, and outcomes of MSD among infants and young children, information used to guide development and implementation of public health interventions to diminish morbidity and mortality from diarrheal diseases.

Perch

The Pneumonia Etiology Research for Child Health (PERCH) study was a case-controlled study led by the International Vaccine Access Center at Johns Hopkins University to expand knowledge of the etiologies of childhood pneumonia. Perch enrolled 4,232 cases and 5,325 controls between 2011-2014 at nine sites in seven countries (The Gambia, Mali, Kenya, Zambia, South Africa, Bangladesh and Thailand).

As a national partner, CVD-Mali played a leading role in the study, selecting participants, collecting specimens and controlling and testing for over 30 pathogens.

The objectives of PERCH were to:
• determine the etiology of pneumonia by integrating results from multiple specimens
• estimate the fraction of pneumonia attributable to pathogens for which vaccines are available or under development (e.g., pneumoniae, respiratory syncytial virus, parainfluenza virus, influenza and S. aureus) as well as other known, but poorly quantified causes of pneumonia in children
• assess risk factors for pneumonia.

The published results of the study can be accessed here.

vida

Vaccine Impact on Diarrhea in Africa (VIDA) is a global health study to assess the causes and burden of diarrhea in children under five and determine the effectiveness of rotavirus vaccine at three sites in sub-Saharan Africa: Mali, Kenya, and The Gambia.

VIDA is a follow-on to the Global Enteric Multicenter Study (GEMS), the largest and most comprehensive study of diarrheal diseases ever conducted in developing countries. Building on the GEMS infrastructure and methodology, VIDA is a 36-month case-control study of moderate-to-severe diarrhea (MSD) in three prototypic low-income countries.

You can read more about the study on CVD-Baltimore’s website, here.