Health Condition 1: null- Uncomplicated Plasmodium falciparum malaria
Conditions
Interventions
Intervention1: piperaquine-dihydroartemisinin (Fixed dose combination) tablets: 2 tablets at 0hr, 8hr, 24hr, 36hr, 48hr and 60hr
Control Intervention1: Artemether-lumefantrine (Fixed dose combination)
Sponsors
Ipca Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients with age between 18 to 65 years 2. Patients with body weight >40 kg at screening. 3. Patients clinically diagnosed of uncomplicated Plasmodium falciparum malaria with a diagnosis confirmed by positive blood smear with asexual forms of P. falciparum parasites (parasite count between 1000 and 100,000 asexual parasites/µL of blood; both inclusive). 4. Patients with axillary temperature >37.5 °C (99.5°F) and/or history of fever during 24 hrs. 5. Patients must understand and be able, willing and likely to fully comply with study procedures and restrictions. 6. Patients willing to come for follow-up as required by study protocol. 7. Written informed consent must be obtained from the patients before participation in this study.
Exclusion criteria
Exclusion criteria: 1. Patients with severe malaria as per WHO criteria. 2. Patients with mixed infection (i.e. malaria due to more than one parasite. 3. Patients with history of congenital prolongation of QTc interval or any other clinical condition known to prolong the QTc interval such as cardiac arrhythmias, clinicalyy relevant bradycardia or severe cardiac disease. 4. Patients with abnormal renal or hepatic function indicated by following laboratory investigations at screening: Serum creatinin > 1.5Ã? upper limit of normal (ULN),aspartate transaminase > 2.5 Ã? ULN, alanine transaminase > 2.5 Ã? ULN, total bilirubin or alkaline phophatase > 2.5 Ã? ULN.5.Patients with disese of blood or haematopoetic organs. 6. Patients with history of psychiatric diseases. 7. Patients with convulsions, seizures and other neurological disorders. 8. Patients with known history of hypersensitivity to artemether or lumefantrine or piperaquine or dihydroartemisinin or any other related compounds. 9. Participation in any investigational drug study within 30 days prior to screening. 10. Pregnant and lactating women. 11. Women of childbearing potential not practicing contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adequate clinical and parasitological responseTimepoint: on day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Fever clearance timeTimepoint: day 1,2,3;Parasite clearance timeTimepoint: Day 1,2,3 | — |
Countries
India
Contacts
Public ContactMr Nitin Chandurkar
Ipca Laboratories Ltd.
Outcome results
None listed