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NCT ID: NCT02236468 Completed - Anemia Clinical Trials

Creating Homestead Agriculture for Nutrition and Gender Equity (CHANGE) in Burkina Faso

CHANGE
Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the long-term impact of the Enhanced Homestead Food Production Program implemented by HKI on household food security and nutritional status, as well as the impact on including additional interventions (BCC on WASH and malaria prevention, distribution of preventive lipid-based nutrient supplements (LNS)) to children aged 6-24 months old, in addition to the standard E-HFP model.

NCT ID: NCT02211729 Completed - Malaria Clinical Trials

A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children

SMCAZ
Start date: May 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine (AQ) will provide an additional reduction in deaths and severe illness in young African children. The secondary objectives include an assessment of the safety and cost-effectiveness of the addition of AZ to SMC with SP+AQ. This a double blind, randomised, placebo controlled trial. The unit of randomisation will be the household. Children aged 3 - 59 months will be randomised to receive four cycles of either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission season. Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59 months of age at the start of each period of drug administration will be eligible for inclusion in the trial provided that parental consent is obtained. Children with a severe, chronic illness or known allergy to one of the study drugs will be excluded. Primary endpoint: Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period Secondary endpoints: 1. incidence of the primary endpoint during the whole study period 2. attendance at a study health centre with a nonmalaria febrile illness 3. attendance at a study health centre with malaria, 4. the prevalence of moderate anaemia at the end of each malaria transmission season, 5. nutritional status at the end of each malaria transmission season, 6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant pneumococci before and at the end of each malaria transmissions season, 7. prevalence of resistance markers to SP at the end of the study, Sample size: 19,200 children (9600 in each country) will be enrolled.

NCT ID: NCT02207816 Completed - Malaria Clinical Trials

An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa

Start date: September 18, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.

NCT ID: NCT02192892 Completed - Malnutrition Clinical Trials

Acceptability Among Children and Caregivers of Amylase Porridges

AMY-01
Start date: June 2014
Phase: N/A
Study type: Interventional

Addition of α-amylase is considered as one of most effective solution to improve energy density of cereal based porridges (WHO, 2008). By adding α-amylase, the viscosity of porridges will be decreased while keeping dry matter content constant. Potential positive impact is to significantly improve efficiency of WFP nutritional programmes targeting vulnerable groups suffering from acute malnutrition. The acceptance of porridges made with α-amylase is tested compared to porridges made without α-amylase among 12-36 months old children and their caregivers. Acceptance is measured based on energy intake. The porridges tested consist of fortified blended Supercereal (12- <24 months) and Supercereal-Plus (24-36 months) based on Corn Soy Blend (CSB) extruded or drum dried, Wheat Soy Blend (WSB), Rice Soy Blend (RSB), all with and without α-amylase, or a commercial porridge, or eeZee bar.

NCT ID: NCT02174900 Completed - Malaria Clinical Trials

Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM)

Start date: October 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.

NCT ID: NCT02151578 Completed - Malaria Clinical Trials

Home Management of Malaria and Pneumonia

HMM/P
Start date: January 2009
Phase: Phase 4
Study type: Interventional

A well-implemented community-based program of early and appropriate treatment of fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction of the less than five mortality rate.

NCT ID: NCT02150993 Completed - HIV-2 Infection Clinical Trials

First-Line Treatment for HIV-2

FIT-2
Start date: January 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

FIT-2 is a multi-country, phase IIb, randomized, non-comparative study, carried out in West Africa (Côte d'Ivoire, Burkina Faso, Senegal, Togo). ARV-naïve HIV-2 infected adult patients will be recruited and followed during 96 weeks. The objective is to evaluate the efficacy and safety of 3 first-line treatments in HIV-2 infected adult patients, in West Africa. A treatment will be considered as effective if more than 55% of patients in that arm attain "global success" at 96 weeks.

NCT ID: NCT02136966 Completed - Growth Failure Clinical Trials

Joint Infant and Young Child Nutrition Program and Malnutrition Prevention

Start date: November 2014
Phase: N/A
Study type: Interventional

Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact evaluation Hypothesis: The fortification of complementary foods associated with a counseling on feeding practices for infants and young children prevents malnutrition in 6-23 months-old children. Objective: to assess the effectiveness of a promotional care package in preventing malnutrition among children aged 6-23 months.

NCT ID: NCT02083380 Completed - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Phase IIb Study to Investigate the Efficacy of OZ439 & Piperaquine Phosphate Co-administered to Adults & Children With Uncomplicated Plasmodium Falciparum.

Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

A randomised, double-blind single-dose (loose combination) study in patients with uncomplicated Plasmodium falciparum malaria. The study will test for efficacy/futility through analyses, using Bayesian methodology. Adults and children will be included through progressive step-down in age following safety analyses. This study investigates the efficacy exposure-response of OZ439/PQP combination in the target populations and if it meets its efficacy objectives, will inform dose setting for Phase III studies.

NCT ID: NCT02071563 Completed - Child Malnutrition Clinical Trials

Effectiveness and Cost-Effectiveness of Four Formulations of Food Supplements for the Prevention of Wasting and Stunting in Burkina Faso

FAQR-Burkina
Start date: March 2014
Phase: N/A
Study type: Interventional

This research will serve as a follow-up on the review of Title II commodities performed by the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso will test the relative effectiveness and cost effectiveness of four supplementary foods in the prevention of MAM and stunting in normal programmatic settings. The aims of this study are to: 1. To compare the effectiveness of four alternative supplementary food commodities in preventing stunting and wasting, and promoting linear growth in children 6 - 23 months in the context of a preventive supplementary feeding program in Burkina Faso. 2. To estimate the relative cost of implementing the supplementary feeding program using each commodity 3. To estimate the relative cost/effectiveness of implementing the program using each commodity.