None listed
Conditions
Brief summary
This study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with drug combination DHA-PIP, and monitored for 42 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of these assessments, the patients will be classified as having therapeutic failure (early or late) or as having an adequate clinical and parasitological response. The proportion of patients experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of the study drug. PCR analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection.
Interventions
Oral tablets of drug contains DHA 40mg – PIP 320 mg will be administered at a dose of expressed as milligram base per kilogram body weight, one daily doses per day for three days.
5kg-9kg = 1/2 tablet once daily for 3 days
10kg- 19kg = 1 tablet once daily for 3 days
20kg-29kg = 1,1/2 tablet once daily for 3 days
30 kg - 39 kg = 2 tablets once daily for 3 days
40 kg- > 60kg = 3 tablets once daily for 3 days
All doses of medicine will be administered under the supervision of a qualified member
Oral tablets of drug contains DHA 40mg – PIP 320 mg will be administered at a dose of expressed as milligram base per kilogram body weight, one daily doses per day for three days. 5kg-9kg = 1/2 tablet once daily for 3 days 10kg- 19kg = 1 tablet once daily for 3 days 20kg-29kg = 1,1/2 tablet once daily for 3 days 30 kg - 39 kg = 2 tablets once daily for 3 days 40 kg- > 60kg = 3 tablets once daily for 3 days All doses of medicine will be administered under the supervision of a qualified member of staff designated by the principal investigator.
Sponsors
Ministry of Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Months to 60 Years
Healthy volunteers
No
Inclusion criteria
- Age between 5 months and above to 60 years old as maximum age; - P. falciparum confirmed by microscopy; - P. Falciparum parasitaemia of 1000-100,000/µl asexual forms; - Presence of axillary temperature more than 37.5 °C or history of fever during the past 24 h; - Ability to swallow oral medication; - Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; - Informed consent from the patient or from a parent or guardian in the case of children aged less than 12 year old; - Informed assent from any minor participant aged more than 12 years and less than 18 years old ; - Consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years.
Exclusion criteria
- presence of general danger signs in children aged under 5 months or signs of severe falciparum malaria according to the definitions of WHO - weight under 5 kg; - mixed or mono-infection with another Plasmodium species detected by microscopy; - presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm); - presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS); - regular medication, which may interfere with antimalarial pharmacokinetics; - history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); - Female patients of child-bearing age, defined as those who menstruate and who are sexually active, will be not included in the study, because they are always not honest to tell on their sexual intercourse experience, which also reflects local culture if they are not yet married. - a positive pregnancy tested or lactating women; and - Unable to or unwilling to take pregnancy test or to use contraception for women of child- bearing age and who are sexually active.
Outcome results
None listed