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Malaria clinical trials

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NCT ID: NCT00694694 Completed - Malaria Clinical Trials

Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria.

CAZAMS
Start date: June 2008
Phase: Phase 3
Study type: Interventional

This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.

NCT ID: NCT00692627 Completed - Clinical trials for Severe Falciparum Malaria

Evaluation of Volume Status, Haemodynamics and Microcirculatory Flow in Adult Patients With Severe Falciparum Malaria

PRiSM
Start date: July 2008
Phase: N/A
Study type: Observational

acidosis, acute renal failure and acute pulmonary oedema are common, and frequently fatal, manifestations of severe P. falciparum malaria. The course of all three might be ameliorated by optimising a patient's intravenous fluid therapy. The fluid treatment of severe malaria is presently empirical, by defining cardiovascular responses to volume replacement we would provide a physiological basis for resuscitation strategies. We will use pulse contour cardiac output monitoring (PiCCOTM) to guide the fluid resuscitation of patients admitted to intensive care with severe malaria. With data collected during the patients' admission we hope to: 1. Assess the degree of hypovolaemia in adults with severe malaria and its contribution to microcirculatory dysfunction and acidosis. 2. To assess the relationships between volume status, haemodynamic parameters and the renal and pulmonary manifestations of severe malaria. 3. To assess the utility of central venous pressure measurement as a guide for fluid administration in patients with severe malaria 4. To investigate the prognostic and clinical utility of central venous oxygen saturation in severe malaria In this way we hope to develop a greater understanding of the pathophysiology of haemodynamic derangement in severe malaria. By comparing the PiCCO derived data with simpler clinical parameters, we hope to determine potential fluid resuscitation strategies - relevant for a resource poor setting - whose efficacy could be confirmed in future trials.

NCT ID: NCT00687895 Completed - Malaria Clinical Trials

Improved Clinical and Microscopy Diagnosis at Primary Health Care in Tanzania

Start date: July 2003
Phase: Phase 4
Study type: Interventional

General objective: To improve the quality of fever case management in children in government health facilities in Tanzania Hypothesis:The training of health workers, as well as provision, training and use of microscopes for malaria diagnosis will improve the treatment of clinical episodes of fever in children while reducing the amount and costs of drugs

NCT ID: NCT00682630 Completed - Malaria Clinical Trials

Bioequivalence Trial of Pyronaridine Artesunate To-be-marketed Tablet to the Clinical Trial Reference Tablet

Start date: September 2007
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults. The secondary objective is to assess the safety of the two formulations.

NCT ID: NCT00682578 Completed - Vivax Malaria Clinical Trials

A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan

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

Malaria is a major public health problem in many provinces of Afghanistan the failure rate of chloroquine (CQ) and amodiaquine (AQ) treated Plasmodium falciparum(Pf) malaria has risen to more than 60% overall and as high as 90% in Jalalabad. CQ remains fully effective against P vivax, and sulphadoxine-pyrimethamine (SP) remains effective against P falciparum (10-15% of cases fail to cure). The current malaria treatment protocol still continuing CQ for P.vivax and adopted Artmisinine based combination therapy (ACT) for treating (Pf) malaria, as most than 50% malaria has being diagnosed clinically, so due to this and other operational reasons the protocol needs to be simplified. By comparing 56 day PCR corrected cure rate of DHA-PPQ with the standard treatment regimen as primary objective and comparing the safety, gametocytecidal effect and parasite clearance time as secondary objectives, our study titled: Randomized, Open Label, controlled, non-inferiority clinical trial for comparison of Efficacy & safety, will provide scientific evidence to lead the simplification and improvement of the standard malaria treatment regimen in Afghanistan; to adopt a policy of treating both vivax and falciparum malaria with the same drug regimen. With a significance level (α) = 0.05 and a power=80%, the calculated sample size is 274 per study arm. Therefore about1100 patients (274 per study-arm: 548 patients with falciaprum malaria and 548 patients with vivax malaria) will be recruited in Malaria reference Centers (MRCs) of three malaria endemic provinces (Nangarhar in the east, Thakhar in the north-east and Faryab in the north-west of country) after signing written inform consent form, according the inclusion and exclusion criteria and will be treated as out patients by giving the randomized drug dose under observation of study team and followed-up daily for 3 days (as treatment course of either arm is once daily dose for three days) and after than weekly up to day 56. and the study is planed to conducted in 3 provinces of Afghanistan for approximately 2 years. Patients will be assessed clinically as well necessary laboratory tests will be performed and all the bio-medical findings will be recorded in special patient case record form, the electronic form of which will be broth to Trop. Med of Mahidol University for final analysis. The patients will be receiving the reasonable transportation cost for follow-up visits as well as one bed-net at the end of enrollment.

NCT ID: NCT00680732 Completed - Malaria Clinical Trials

Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component

Start date: June 2003
Phase: Phase 4
Study type: Interventional

Our objective was to investigate the importance of malaria infection/disease during pregnancy and more particularly during the first trimester; we also looked at the maternal-foetal interactions and their influence on the subsequent child's response to malaria infections during the first year of life. This study was carried out !in the same population recruited for the IUGR study (NCT00642408).

NCT ID: NCT00677833 Completed - Malaria, Falciparum Clinical Trials

Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

Start date: June 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.

NCT ID: NCT00675064 Completed - Malaria Clinical Trials

Single-Blind, Placebo-Controlled, Randomized Study Testing Single Ascending Doses Of GSK369796 In Healthy Subjects

Start date: May 2, 2008
Phase: Phase 1
Study type: Interventional

This study will examine safety of single doses of GSK369796 in healthy subjects, along with some test to examine how quickly GSK369796 gets in your blood, and how long it takes your body to get rid of it.

NCT ID: NCT00673166 Completed - Malaria Clinical Trials

Evaluation of Local Mechanisms for Staff Motivation to Reduce Hospital Mortality

Start date: January 2008
Phase: N/A
Study type: Interventional

We observed in a randomised intervention trial in Bissau that mortality due to malaria could be reduced by half by adding a small monetary incentive to the staff and strict follow-up of a standard protocol for available drugs. The Government and donors are not able to sustain such incentives. We intend to evaluate whether strict organisation of a cost recovery system and the use of part of the funds for staff incentives would improve performance of the staff and contribute to reduction of hospital and post-discharge mortality.

NCT ID: NCT00669084 Completed - Malaria Clinical Trials

Innate and Acquired Resistance to Plasmodium Falciparum Malaria in Mali

Start date: April 21, 2008
Phase:
Study type: Observational

This study, sponsored by NIAID and the University of Bamako, Mali, will identify genetic and other factors that may protect against severe malaria in some children. Children between 6 months and 17 years of age who live in Kenieroba, Fourda or Bozokin villages in Mali may enroll in the study. Participants have a blood sample collected by finger prick with a small needle. The blood is examined for gene variants that influence the severity of disease in children exposed to the malaria parasite. Children who develop a fever or other symptoms of malaria are evaluated and treated in Kenieroba s health center for up to 5 years from entering the study, or until they reach 18 years of age. The children are treated with artesunate and amodiaquine. Children with severe disease are treated with quinine. One tablespoon of blood is drawn from the children for study. At the end of the dry season and the wet season, a subset of 200 healthy children are asked to provide 1 or 2 tablespoons of blood, drawn through a needle placed in a vein in the arm. Additional research blood samples may be requested from children between 2 and 17 years old. Blood will not be taken from any child more than twice a year. ...