None listed
Conditions
Brief summary
The general objective of this study is to assess the efficacy and safety of Dihydroartemisinin-Piperaquine in Kvav Health Centre (Siemreap), in Kbal Romeas ( Stung Treng) and in Koh Ngek Health Centre (Mondulkiri) for the treatment of uncomplicated Plasmodium falciparum malaria in Cambodia. The primary objectives are: *to measure the clinical and parasitological efficacy of Dihydroartemisinin-Piperaquine for the treatment of uncomplicated P. falciparum in patients aged between 2 and 60 years old, except unmarried 12-18 females, suffering from P. falciparum by determining the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy; *to differentiate recrudescence from new infection by polymerase chain reaction (PCR) analysis for P. falciparum malaria; The secondary objectives are: *to evaluate the incidence of adverse events; and *to formulate recommendations and to enable the Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated. The exploratory objectives are: *to assess the in vitro susceptibility of P. falciparum solates to dihydroarteminisinin, piperaquine at D0 and Day of recrudescence; *to determine the polymorphism of molecular markers of Plasmodium falciparum and Kelch gene
Interventions
DHA-PIP (DHA-PIP Trademark, Holley Kin Pharmaceutical Co. Ltd, Guangzhou, China): one tablet of DHA-PIP contains 40mg of dihydroartemisinin (DHA) and 320 mg piperaquine (PIP). It is an oral [by mouth] administration, one dose a day for 3 consecutive days. An adult dose (from 40 kg to 60kg body weight or more than 15 years old) consisted of three doses of 3 tablets over consecutive days (Total dose 9 tablets). The approximate total adult dose was 2-4 mg/kg for DHA and 20mg/kg for PIP.
All doses
DHA-PIP (DHA-PIP Trademark, Holley Kin Pharmaceutical Co. Ltd, Guangzhou, China): one tablet of DHA-PIP contains 40mg of dihydroartemisinin (DHA) and 320 mg piperaquine (PIP). It is an oral [by mouth] administration, one dose a day for 3 consecutive days. An adult dose (from 40 kg to 60kg body weight or more than 15 years old) consisted of three doses of 3 tablets over consecutive days (Total dose 9 tablets). The approximate total adult dose was 2-4 mg/kg for DHA and 20mg/kg for PIP. All doses of medicine will be administered under the supervision of a qualified member of the staff designated by the principal investigator. The study patients will be observed for 30 min after medicine administration for adverse reactions or vomiting. Any patient who vomits during this observation period will be re-treated with the same dose of medicine and observed for an additional 30 min. If the patient vomits again, he or she will be withdrawn and offered rescue therapy. The patients are recommended to stay at the health facilities until they complete the treatment course for malaria infection.
Sponsors
Ministry of Health, Cambodia
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
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 by microscopy; P. falciparum parasitaemia of 500-100,000/microliter asexual forms; *presence of axillary above to 37.5 °C or history of fever during the past 24 h; *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; and *informed consent from the patient or from a parent or guardian in the case of children aged less than 12 years; *informed assent from any minor participant aged more than 12 years and less than 60 years; and *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 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