None listed
Conditions
Brief summary
Title: Invivo efficacy and safety of artemether/lumefantrine and dihydroartemisinin/piperaquine [DHA/PQP] for the treatment of uncomplicated Plasmodium falciparum malaria in public health facilities in Tanzania. Purpose: To assess the efficacy and safety of the current first and second line treatments to support updating of the national malaria treatment policy. Objective: To assess the efficacy and safety of artemether/lumefantrine and DHA/PQP for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Ikwiriri and Kibiti in Rufiji district and Ipinda in Kyela district. Study Period: The study will be conducted between December 2014 to June 2015. Study Design: Two cohorts’ prospective study in sequential enrollments. Patient population: Febrile patients aged 6 months and above, excluding female minors 12-17 years, with confirmed uncomplicated P. falciparum infection will be enrolled. Sample Size: A total of 88 patients per treatment arm in each site will be enrolled. Treatments and follow-up: artemether/lumefantrine given twice daily for three days and dihydroartemisinin/piperaquine given once daily for 3 days. Clinical and parasitological parameters will be monitored over a 28-day (artemether/lumefantrine ) or 42-day (dihydroartemisinin/piperaquine) 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: The frequency and nature of adverse events Optional exploratory endpoints: to determine the polymorphism of molecular markers for artemisinin resistance.
Interventions
To assess the efficacy and safety of artemether/lumefantrine (20mg/120mg: 3 day regimen of twice daily dose of 1 tablet for 5-14 kg; 2 tablets for 15-24 Kg; 3 tablets for 25-34 and 4 tablets for gretaer than or equal to 35 kg) and (ii) and dihydroartemisinin/piperaquine (4 mg/kg dihydroartemisinin and 18 mg/kg piperaquine once a day for 3 days) for the treatment of uncomplicated P. falciparum infection. The treatment will be taken orally under direct supervision by the health worker. Eligibile s
To assess the efficacy and safety of artemether/lumefantrine (20mg/120mg: 3 day regimen of twice daily dose of 1 tablet for 5-14 kg; 2 tablets for 15-24 Kg; 3 tablets for 25-34 and 4 tablets for gretaer than or equal to 35 kg) and (ii) and dihydroartemisinin/piperaquine (4 mg/kg dihydroartemisinin and 18 mg/kg piperaquine once a day for 3 days) for the treatment of uncomplicated P. falciparum infection. The treatment will be taken orally under direct supervision by the health worker. Eligibile subjects will be treated for three days and followed up for 28 days (artemether/lumefantrine or 42 days (dihydroartemisinin/piperaquine).
Sponsors
Ifakara health Institute
Study design
Allocation
Non-randomised trial
Intervention model
Other
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 six months and above, excluding female minors 12-17 years old 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000–200,000/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 8. informed assent from any minor participant aged from 12 to 17 years age of majority years; and 9. consent for pregnancy testing from female of child-bearing potential and are 18 years and above.
Exclusion criteria
1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; 2. weight under 5 kg; 3. mixed or mono-infection with another Plasmodium species detected by microscopy; 4. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference belo 115 mm) 5. 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); 6. regular medication, which may interfere with antimalarial pharmacokinetics; 7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); 8. a positive pregnancy test or breastfeeding; and 9. unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and aged 18 years and above and who are sexually active.
Outcome results
None listed