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Malaria clinical trials

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NCT ID: NCT00593398 Completed - Clinical trials for Plasmodium Falciparum Malaria

Malarial Immunity in Pregnant Cameroonian Women

Start date: September 2008
Phase:
Study type: Observational

Malaria is caused by a parasite and is a health problem for mothers and fetuses (unborn infants). The Cameroonian Ministry of Health recommends that all pregnant women should take the drug sulfadoxine-pyrimethamine (also known as SP) every two months during pregnancy to avoid malaria. The purpose of this study is to find out how effective SP is in preventing pregnant Cameroonian women from getting malaria. Additional goals of this study are to see whether: SP prevents malaria parasites from causing changes in the placenta; SP prevents or helps women make a substance that keeps parasites from accumulating in the placenta; and whether SP affects the amount of protection a mother transfers to her baby. Participants will include 1,160 pregnant women, ages 15-50 years, and 216 babies born residing in Ngalii II and Ntouessong. Study procedures will include monthly blood samples from pregnant women and babies. Volunteers may participate in this study for up to 19 months.

NCT ID: NCT00587249 Completed - Clinical trials for Plasmodium Falciparum Malaria

ICC-1132 - Candidate Vaccine Against P Falciparum Malaria

Start date: July 2002
Phase: Phase 1
Study type: Interventional

The purposes of this study are to evaluate the safety and immune responses (the body's defense system) to an investigational malaria vaccine called ICC-1132. Three different doses of the vaccine will be studied in 3 groups of people, and the results will be compared. The study will involve about 80 healthy volunteers, 18-45 years of age, who will receive an injection of a specific dose of the vaccine in their arm on 2 or 3 different days. Blood samples will be collected approximately 15 times for laboratory studies. Volunteers will record their temperature twice per day. Volunteers will complete a daily symptom diary for 7 days after each vaccination. Volunteers will participate in the study for up to 13 months.

NCT ID: NCT00563914 Completed - Malaria Clinical Trials

A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria

Start date: October 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective is to assess the safety of different doses of ferroquine with artesunate (AS) in adult African patients with uncomplicated malaria. The secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.

NCT ID: NCT00561899 Completed - Malaria Clinical Trials

Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Children

Start date: August 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without compromising the development of malaria immunity or encouraging drug resistance. The effect of IPT in children in the prevention of malaria has been evaluated in a number of trials in areas of seasonal malaria transmission. Results from these trials have shown that IPTc provided between 40% - 86% protection against clinical malaria. In 2006, a trial that compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia. Preliminary results of the trial have shown that the treatment was very effective as only 4% (45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic. Tolerability was assessed in a subset of 1100 children and the results showed that about 13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of the study subjects. Severe adverse events were rare. Thus it is important to investigate if other drug regimens might be equally effective in preventing malaria but less likely to cause adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions during the months of September, October, and November. To determine the prevalence of side effects following drug administration participants in each treatment group will be visited at home three and seven days after each round of drug administration and a side effects questionnaire completed. To help establish whether these adverse events are drug related, the same questionnaire will be administered after each treatment round, to 286 age-matched children who are not part of the trial. The primary ends points will be the incidence of adverse events.

NCT ID: NCT00550160 Completed - Malaria Clinical Trials

The Synergistic Effects of Home-management and Intermittent Preventive Treatment of Malaria in Children

KNUST-COMDIS
Start date: April 2007
Phase: Phase 4
Study type: Interventional

This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home management of malaria (HMM) programme using AQ+AS in Ghana. The study will be conducted in the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone. The study will run in three phases; a preparatory phase to set up and obtain baseline morbidity data from a cross-sectional survey; an intervention phase and a post intervention phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study children randomly selected will receive three full treatment courses of AS+AQ intermittently during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs) will administer all courses of IPTc. The first dose of each course will be directly observed by the CDDs who will educate mothers or caregivers to administer subsequent doses appropriately at home. Follow up visits to homes will be done by CDDs and field supervisors to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria and other secondary outcomes will be compared with those of another cohort of 546 study children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ when necessary during the observation period.

NCT ID: NCT00549003 Completed - Malaria Clinical Trials

Efficacy and Cost Effectiveness of Malaria Diagnosis Procedures and the Rational Use of ACT in Zanzibar

ZRDT
Start date: February 2005
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess performance and cost-effectiveness of rapid diagnostic test(RDT) aided malaria diagnosis versus symptom-based/clinical diagnosis in patients of all ages with reported fever last 48 hours alone in primary health care settings in Zanzibar.

NCT ID: NCT00545935 Completed - Malaria Clinical Trials

Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso

Start date: July 2007
Phase: Phase 2
Study type: Interventional

The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.

NCT ID: NCT00544024 Completed - Malaria Clinical Trials

Mefloquine Bioequivalence Among 3 Commercially Available Tablets.

Start date: March 2004
Phase: N/A
Study type: Observational

The objective of this study was to determine the bioequivalence among three commercial tablet formulations of MQ, i.e. Lariam, Mephaquin, and Mefloquine-(AC Farma) when given in combination with artesunate.

NCT ID: NCT00541385 Completed - Malaria Clinical Trials

Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric Patients

Start date: October 2007
Phase: Phase 3
Study type: Interventional

The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate (ACPR) of more than 90%. Secondary objectives of this clinical study are to compare the efficacy (non-inferiority) and safety of the PA granule formulation compared to Coartem® (ie, the combination of artemether/lumefantrine [AL]) crushed tablets in a paediatric population and to assess the safety of the PA granule formulation.

NCT ID: NCT00540410 Completed - Malaria Clinical Trials

Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Start date: September 2007
Phase: Phase 4
Study type: Interventional

Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject. Secondary objectives: For the first attack: To compare the two groups of treatment in terms of: - D14 efficacy - Parasitological and fever clearance - Clinical and biological tolerability - Evolution of gametocyte carriage - Cardiac tolerability (QTc) For the repeated attacks: To compare the two groups of treatment in terms of: - D14 and D28 clinical and parasitological effectiveness (PCR adjusted) - Clinical and biological tolerability - Proportion of patients without fever at D3 - Proportion of patients without parasite at D3 - Compliance - Impact on anaemia During the total follow-up of the cohort: To compare the two groups of treatment in term of: - Treatment incidence density - Impact of repeated treatment on clinical and biological safety - Impact of repeated treatment on hearing capacity