Clinical Trials Logo

Filter by:
NCT ID: NCT01697787 Completed - Malaria Clinical Trials

Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso

Start date: October 2012
Phase: Phase 4
Study type: Interventional

This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid Diagnosis Tests (RDTs) compared to the microscopy.

NCT ID: NCT01668745 Recruiting - Measles Vaccine Clinical Trials

Trial of Additional Measles Vaccine to Reduce Child Mortality. Burkina Faso.

Start date: May 2013
Phase: Phase 4
Study type: Interventional

Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival. Objective: To evaluate in a multi-center RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention. Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated. Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each site the investigators intend to enroll at least 4050 children in Burkina Faso. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored. Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.

NCT ID: NCT01635647 Completed - Malaria Clinical Trials

A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

Start date: November 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.

NCT ID: NCT01619878 Completed - Clinical trials for Acute Uncomplicated Falciparum Malaria

Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

Start date: October 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.

NCT ID: NCT01603251 Completed - Malaria Clinical Trials

Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission

ACTIVE
Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.

NCT ID: NCT01577771 Completed - Clinical trials for Pneumococcal Infections

Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso

PCV13-Bobo
Start date: February 2013
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso. Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and 9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart. Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later. Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA assessments pre-vaccination and 1 month post-vaccination. The immunogenicity and reactogenicity of PCV13 in the "standard schedule" groups (e.g. 6, 10, 14 weeks for infants and single dose for toddlers) will be compared to that observed in the PCV13 licensure trials. Within each age group the alternative schedule will be compared to the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage (infants only).

NCT ID: NCT01555255 Active, not recruiting - Malaria Clinical Trials

Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria

Start date: November 2010
Phase: N/A
Study type: Observational

This study seeks to determine whether screening pregnant women for malaria with malaria rapid diagnostic tests (RDTs) may detect placental infection and predict risk of poor birth outcomes due to malaria in areas of varied malaria transmission in Africa.

NCT ID: NCT01517230 Completed - Malaria Clinical Trials

Can Mass Media Campaigns Reduce Child Mortality

Start date: March 2012
Phase: N/A
Study type: Interventional

A cluster-randomised trial will be undertaken in Burkina Faso to investigate whether a comprehensive mass media campaign using local radio stations can change behaviours on a scale large enough to result in measurable and sustainable reductions in under-five child mortality. It is hypothesised that as a result of the scale and multi-pronged nature of the campaign, reductions of between 10% and 20% in child mortality will be achieved.

NCT ID: NCT01506648 Completed - Bioavailability Clinical Trials

Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food

Start date: January 2011
Phase: N/A
Study type: Observational

Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study

NCT ID: NCT01445938 Terminated - Malaria Clinical Trials

Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

Start date: October 2011
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria Secondary Objectives: - To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs) - To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria - To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria - To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A