Clinical trials: in Niger
Mortality, Antimicrobial Resistance
Azithromycin for Child Survival in Niger II
Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR).
- Trial name
- AVENIR II (NCT06358872)
- Testing
- Azithromycin for Oral Suspension
- Where
- Niger
- Volunteers
- 3,300,000 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Mortality, Resistance Bacterial
Azithromycin for Child Survival in Niger: Mortality and Resistance Trial
The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include…
- Conditions
- Mortality, Resistance Bacterial, Child, Only
- Trial name
- AVENIR (NCT04224987)
- Testing
- Azithromycin
- Where
- Niger
- Volunteers
- 864,493 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Malaria
Integrating the Guardian Spatial Emanator Within AVENIR II
This study will evaluate the implementation of integrating Guardian spatial emanators into the existing AVENIR II azithromycin mass drug administration program in Niger.
- Trial name
- GUARD-AV (NCT07712263)
- Testing
- Spatial Emanator
- Where
- Niger
- Volunteers
- 150,000 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Malnutrition Severe, Vaccination
OptiMAx Will Test Whether SQ-LNS Incentivises Vaccination Uptake in Rural Chad and Niger, With a Cost Effectiveness Analysis. It Will Also Look at Whether Having Received SQ-LNS Before Becoming Malnourished Leads to Better Outcomes for Children Treated Under the OptiMA Protocol.
Malnutrition and infectious disease form a vicious circle, posing a double threat to vulnerable children in low- and middle-income countries.
- Trial name
- OptiMAx (NCT07592260)
- Testing
- small quantity lipid-based supplement (SQ-LNS)
- Where
- 2 sites in Chad, Niger
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Alliance for International Medical Action
Moderate Acute Malnutrition (MAM)
Development, Feasibility and Acceptability of Recipes for Locally Available, Specially Formulated Foods for the Management of Moderate Acute Malnutrition in Niger (Related to NCT06382857 Protocol)
The study consisted of two phases. Phase 1 was a recipe development phase, which aimed to identify recipes that meet ≥80% of the recommended nutrient profile for Specially Formulated Foods (SFF) used in the standard management of…
- Trial name
- LAF (NCT07506213)
- Testing
- Locally Available Food
- Where
- Niger
- Volunteers
- 30 people
- Sponsor
- Epicentre
Trachoma
Azithromycin Reduction to Reach Elimination of Trachoma
The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maradi, Niger.
- Trial name
- ARRET (NCT04185402)
- Testing
- Azithromycin
- Where
- Niger
- Volunteers
- 3,931 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria
This study aims to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for…
- Trial name
- KALUMA (NCT05842954)
- Testing
- KLU156, Coartem
- Where
- 33 sites in Burkina Faso, Côte d’Ivoire and 10 more
- Volunteers
- 1,720 people
- Sponsor
- Novartis Pharmaceuticals
Plasmodium Falciparum Malaria (Uncomplicated)
A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.
A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the…
- Trial name
- DeTACT-Africa (NCT03923725)
- Testing
- Artemether-lumefantrine+ Amodiaquine (AL+AQ), Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)
- Where
- 8 sites in Burkina Faso, Democratic Republic of the Congo and 6 more
- Volunteers
- 2,583 people
- Sponsor
- University of Oxford
Pediatric Cancer
Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa
The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group.
- Trial name
- RFAOP (NCT03803735)
- Where
- 14 sites in Burkina Faso, Cameroon and 10 more
- Volunteers
- 10,000 people
- Sponsor
- French Africa Pediatric Oncology Group
Mortality, Child Health
Azithromycin for Child Survival in Niger: Delivery Trial
This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes.
- Conditions
- Mortality, Child Health, Implementation
- Trial name
- AVENIR (NCT04774991)
- Testing
- Azithromycin for Oral Suspension
- Where
- Niger
- Volunteers
- 10,925 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis
Novel Triple-dose Tuberculosis Retreatment Regimen
To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent…
- Conditions
- Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Resistance to Tuberculostatic Drugs
- Trial name
- Tri-Do-Re (NCT04260477)
- Testing
- 6EH³R³Z, 6EHRZ
- Where
- Niger
- Volunteers
- 370 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Pneumococcal Carriage
Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV)
The aim of this study is to assess the impact of a mass campaign with a single, fractional dose of Pneumosil®, a PCV10, on VT carriage.
- Trial name
- fPCV (NCT05175014)
- Testing
- PCV10 full dose, PCV10 fractional dose
- Where
- Niger
- Volunteers
- 44,618 people, healthy volunteers welcome
- Sponsor
- Epicentre
Cutaneous Leishmaniasis
Epidemiology of Cutaneous Leishmaniasis in Niger, Mali, Togo : Mapping of Clinical Cases, Species, Reservoirs and Vectors of the Disease
Cutaneous leishmaniasis is a neglected tropical disease caused by parasites belonging to the genus Leishmania. This infection can cause skin and sometimes mucous membrane lesions with significant damage.
- Trial name
- LEISHAFRICA (NCT06692985)
- Testing
- Clinical and epidemiological data, Parasitological samples, Assessment of clinical course and response to treatment
- Where
- 3 sites in Mali, Niger and 1 more
- Volunteers
- 270 people
- Sponsor
- Centre Hospitalier de Cayenne
Adolescent Development
Adolescent Transition West Africa
This trial will serve as an outcome evaluation of 'Adolescent Transition in West Africa' (ATWA), a school-based program in Mali, Burkina Faso, and Niger for adolescents ages 10-19.
- Trial name
- ATWA (NCT05396664)
- Testing
- ATWA
- Where
- 3 sites in Burkina Faso, Mali and 1 more
- Volunteers
- 4,300 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Malnutrition, Child
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to < 24 months with uncomplicated acute malnutrition in terms of programmatic…
- Trial name
- NCT06382857
- Testing
- MDF, RUTF, RUSF
- Where
- Niger
- Volunteers
- 7,356 people
- Sponsor
- Epicentre
Malnutrition, Child
Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition
This study will compare the acceptability a microbiome-directed food (MDF) with standard formulations of therapeutic/supplementary foods for the treatment of acute malnutrition using a 2 x 2 crossover design.
- Trial name
- NCT05551819
- Testing
- MDF then RUTF/RUSF, RUTF/RUSF then MDF
- Where
- 2 sites in Niger
- Volunteers
- 274 people
- Sponsor
- Epicentre
Severe Rotavirus Gastroenteritis
Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger
The study is a double-blinded, randomized, placebo-controlled, trial with two groups of infants receiving vaccine or placebo to assess the efficacy and safety of BRV-PV.
- Trial name
- ROSE (NCT02145000)
- Testing
- Rotavirus vaccine (BRV-PV)
- Where
- Niger
- Volunteers
- 6,586 people, healthy volunteers welcome
- Sponsor
- Epicentre
Orthopedic Disorder
3D-printing and Acces to Tele Rehabilitation
This study will investigate whether 3D printing of orthoses (night splints and AFO/KAFO for walking, further named as dynamic AFO/KAFO) for the lower limbs can help to improve the limited accessibility to orthopaedic devices in…
- Trial name
- Imp&acte3D (NCT05947630)
- Testing
- Ankle Foot Orthosis (AFO), Knee Ankle Foot Orthosis (KAFO)
- Where
- 4 sites in Mali, Niger and 1 more
- Volunteers
- 79 people
- Sponsor
- Lieven De Maesschalck
Vitamin A Deficiency, Iron-deficiency
Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Rural Niger Villages
The primary hypothesis is that introduction of food-to-food fortified products through a rural Hub-and-Spoke incubator system contributes to an improved food environment and availability of micronutrients to these communities.
- Trial name
- NigerMPS (NCT05893901)
- Where
- Niger
- Volunteers
- 3,600 people, healthy volunteers welcome
- Sponsor
- Purdue University
to Contribute to a Better Control of COVID-19 in Children in Niger
COVID-19 IN CHILDREN IN NIGER, 2020
On January 30, 2020, the WHO declared COVID-19 a global health emergency. Children were affected with less severe forms. Niger had implemented measures in a context where children are a source of contamination.
- Trial name
- NCT05886179
- Testing
- cross-sectional study
- Where
- Niger
- Volunteers
- 572 people
- Sponsor
- Centre de Recherche Médicale et Sanitaire