None listed
Conditions
Brief summary
The study is to evaluate the efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated P. falciparum in Cambodia
Interventions
Patients with P. falciparum infection are orally treated with standard 3-day dihydroartemisinin-piperaquine (Duo-Cotecxin Registered Trademark, DHA 40 mg and PP 320 mg, Zhejiang Holley Nanhu Pharamaceutical Co. Ltd, Jiaxing, Zhejiang province, China). Supervised dihydroartemisinin-piperaquine is administered once daily for 3 days (D0, 24h, 48h) by the research team. Dosing is based on body weight, in accordance with the national treatment guidelines: (i) < 19 kg, 1 tablet/day; (ii) 19-29 kg, 1.5
Patients with P. falciparum infection are orally treated with standard 3-day dihydroartemisinin-piperaquine (Duo-Cotecxin Registered Trademark, DHA 40 mg and PP 320 mg, Zhejiang Holley Nanhu Pharamaceutical Co. Ltd, Jiaxing, Zhejiang province, China). Supervised dihydroartemisinin-piperaquine is administered once daily for 3 days (D0, 24h, 48h) by the research team. Dosing is based on body weight, in accordance with the national treatment guidelines: (i) < 19 kg, 1 tablet/day; (ii) 19-29 kg, 1.5 tablets/day; (iii) 30-39 kg, 2 tablets/day; (iv) > or = 40 kg, 3 tablets/day. For children unable to swallow tablets, DHA-PP was dissolved in 5 ml of water. Patients are observed for one hour post-dosing and redosed full or half dose if vomiting occurred within 30 minutes or between 31 and 60 minutes, respectively. Those who vomited after the second dose are withdrawn from the study and given parenteral rescue treatment (intramuscular artemether).
Sponsors
Ministry of Health of Cambodia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
- age between 2 and 60 years except unmarried females between 12 and 18 years old (potential unpredicted pregnancy); - mono-infection with P. falciparum detected by microscopy; P. falciparum parasitaemia of 500-200,000/microliter asexual forms; - ability to swallow oral [by mouth] medication; - ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule - Patients were evaluated clinically and parasitologically based on the specific inclusion criteria: over two years of age; fever (above 37.5 degrees Celsius) or history of fever in the last two days; P. falciparum mono-infection with parasite density between 500 to 200,000 asexual parasites/microliter and the exclusion criteria of the study; - If a patient is eligible for the study the researcher asks if the patient can involve in the study by explaining all the process, procedure and all potential risks of drug side effects. - If the patient agrees to participate in the study then the patient needs to sign in an inform consent. - The patients are to stay at the health facilities for 3 or 4 days until the parasites completely clear from their bodies - The patient has to come back to the study site for follow up on weekly basis over 42 days. - During the follow up the patient receives the physical and parasitological examination (i.e, blood slide).
Exclusion criteria
*presence of general danger signs in children aged under 5 years 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 < 110 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); *unmarried women 12-18 years old; *a positive pregnancy test or breastfeeding; *unable to or unwilling to take a pregnancy test or unwilling to take pregnancy test or contraceptives (for women of child-bearing age).
Outcome results
None listed