ADAPT Phase 2
- Conditions
- HIV/AIDSMalaria
- Registration Number
- PACTR201311000659400
- Lead Sponsor
- iverpool School of Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 489
1.Age ¿15 to ¿65 years old
2.Female patients, if of child-bearing potential must not be pregnant and lactating
3.Body weight > 35 kg
4.Initial parasite densities not exceeding 200,000/µL.
5.Presence of fever (axillary temperature ¿ 37.5 °C or oral ¿ 38 °C) or a history of fever or malaria-like symptoms (nausea, vomiting, myalgia or arthralgia) in the past 24 hours
6.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if a subject is <18 years of age) has been informed of all pertinent aspects of the study and that all questions by the subject have been sufficiently answered. Assent will be obtained from subjects <18 years of age.
7.Willingness and ability to comply with scheduled visits, supervised treatment administration, laboratory tests, and other study procedures.
8.Ability to swallow oral medications.
1.Patients with severe malaria as per WHO criteria.
2.Patients with mixed infection with another Plasmodium species at the time of presentation (including P. vivax, P. ovale and P. malariae).
3.Hemoglobin (Hb) level of < 7 gm/dL.
4.A female patient who is lactating or pregnant at screening.
5.Use any antimalarial treatment and other drugs with antimalarial activity except cotrimoxazole 1 month prior to the screening
6.Known allergy to any of the components or by-products of the ACT which is being used in the clinical trial. This may include artesunate, artemether, artemisinin-derived products, lumefantrine, piperaquine, or amodiaquine.
7.Gastrointestinal dysfunction that could alter absorption or motility (e.g., diarrhoea defined as > 3 episodes of watery stools in the previous 24 hours or patients who have had 3 episodes of vomiting within 24 hours prior to screening).
8.Participation in any investigational drug trial during the 30 days prior to screening.
9.Evidence of clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, neurological, psychiatric or endocrine diseases or other abnormalities (other than malaria) that may increase the risk associated with study participation
10.Clinical symptoms of febrile conditions due to diseases other than malaria (eg measles, acute respiratory tract infections) that may compromise the evaluation of the response to the study medication.
11.Patients who have had a splenectomy as confirmed by history or clinical examination.
12.Patients with a history of epilepsy or convulsions.
13.Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method malaria parasitemia
- Secondary Outcome Measures
Name Time Method adverse events;gametocytes;Axillary Temperature;piperaquine and lumefantrine concentrations;Hemoglobin concentration