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NCT ID: NCT02497612 Terminated - Clinical trials for Plasmodium Falciparum Infection

To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

FALCI
Start date: July 25, 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children. Secondary Objectives: - To evaluate the efficacy of OZ439/FQ: - To determine the incidence of recrudescence and re-infection. - To determine the time to relief of fever and parasite clearance. - To evaluate the safety and tolerability of OZ439/FQ in adults and children. - To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. - To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.

NCT ID: NCT01472211 Terminated - Diarrhea Clinical Trials

Water-based Zinc Intervention Trial in Zinc Deficient Children

Start date: September 2011
Phase: Phase 0
Study type: Interventional

The overall aim of this trial is to determine whether the use of the household-based water treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status and health status of vulnerable populations in developing country rural settings with poor access to potable water. To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc enriched water) a double blind controlled field efficacy trial will take place over a period of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc enriching filter), placebo (filter) and control group (disinfection tables). During the trial the following outcomes will be monitored: zinc status and growth rate of the participating children, zinc status and pregnancy outcome in a sub-sample of pregnant women (pregnancy sub-study), diarrhea prevalence in all participating subjects, water quality, zinc enrichment of water, and modality and consistency of use of the LSF-device by the study population. The study hypotheses are: 1) the use of the LSF-device will reduce microbiological contamination of the household water, 2) the use of the LSF-device will increase zinc intakes and serum zinc concentration in preschool children, 3) the use of the LSF-device will increase zinc intakes and serum zinc concentration in pregnant women, 4) the achievement of 1 and 2 will improve growth and lower frequency and length of diarrhea episodes in participating preschool children, 5) the achievement of 1 and 3 will improve pregnancy outcome and lower frequency and length of diarrhea episodes in participating pregnant women, 6) the use of the LSF-device will lower frequency and length of diarrhea episodes in participating households members.

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

NCT ID: NCT01103713 Terminated - Clinical trials for Asymptomatic Parasitemia In Pregnancy

Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia. The subjects will be given 3 day dosing regiment of the fixed-dose combination of Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction data will be evaluated on Day 28 as primary endpoint.

NCT ID: NCT01103063 Terminated - Clinical trials for Intermittent Preventive Treatment In Pregnancy (IPTp)

Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

Start date: October 2010
Phase: Phase 3
Study type: Interventional

The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.

NCT ID: NCT00988507 Terminated - Clinical trials for Plasmodium Falciparum Infection

Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

FARM
Start date: October 2009
Phase: Phase 2
Study type: Interventional

Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment. Secondary objectives: - To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment. - To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine associated with artesunate and one dose level of ferroquine alone. - To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse sampling schedules.

NCT ID: NCT00739206 Terminated - Malaria Clinical Trials

Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.

Start date: August 2008
Phase: Phase 2
Study type: Interventional

The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria. The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.

NCT ID: NCT00153777 Terminated - HIV Infection Clinical Trials

Cellulose Sulfate and HIV Transmission Among Women

Start date: July 2005
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine the effect of cellulose sulfate on the transmission of HIV to women via vaginal intercourse. The secondary objectives are the effect on the transmission of gonorrhea and chlamydia via the same route. The study hypothesis is that there will be no effect.