None listed
Conditions
Brief summary
Title: Efficacy and safety of Dihydroartemisinin-Piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in District Headquarter Hospital Zhob of Balochistan province and Tehsil HQ Hospital Sadda Kurram Agency FATA, Pakistan Purpose: To assess the efficacy and safety of Dihydroartemisinin-Piperaquine for treatment of uncomplicated falciparum malaria Objective: To assess the efficacy and safety Dihydroartemisinin-Piperaquine for the treatment of uncomplicated P. falciparum malaria infections Study Sites: study will be conducted in two hostpitals: health centres: District Headquarter Hospital Zhob of Balochistan province and Tehsil HQ Hospital Sadda Kurram Agency FATA Study Period: The study will be conducted from October to December 2015 Study Design: Single arm prospective study. Patient population: Febrile patients aged 6 months and above excluding 12-17 old female minors and unmarried females aged 18 years and above, with confirmed uncomplicated P. falciparum infection Sample Size: 88 patients per site. For the two sites a total of 176 subjects will be enrolled. Treatments and follow-up: Dihydroartemisinin-Piperaquine (daily dose for 3 days) will be given. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy and safety. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Day 3 malaria positivity rate will determined. Secondary endpoints: 1. The frequency of adverse events. 2. Frequency of molecular markers for artemisinin resistance (K13)
Interventions
To assess the efficacy and safety of Dihydroartemisinin+Piperaquine (4 mg/kg DHA and 18 mg/kg Piperaquine once a day for 3 days) for the treatment of uncomplicated P. falciparum infection. The treatment will be given in tablets by oral. Eligible subjects will be treated for three days and followed up for 42 days.
The daily doses of the study medicine will be administered under direct supervision.
Sponsors
Directorate of Malaria Control, Ministry of National Health Services Regulations and Coordination, NIH, Islamabad
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. age between six months and above with the exception of 12-17 years olde female minors and unmarried women above 18 years; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 500–200,000/microliter asexual forms; 4. presence of axillary temperature greater or equal to 37.5 degrees C or history of fever during the past 24 h 5. ability to swallow oral medication; 6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; 7. informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years. 8. informed assent from any minor participant aged from 12 to 17 years; and 9. consent for pregnancy testing from married female aged 18 years and above.
Exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe 2. falciparum malaria according to the definitions of WHO; 3. weight under 5 kg; 4. mixed or mono-infection with another Plasmodium species detected by microscopy; 5. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference below 115 mm) 6. 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); 7. regular medication, which may interfere with antimalarial pharmacokinetics; 8. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); 9. a positive pregnancy test or breastfeeding of married women aged 18 years and above; and 10. 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