A clinical trial to study the effects of piperaquine-dihydroartemisinin combination and artemether-lumefantrine combination in patients with uncomplicated Plasmodium falciparum malaria.

Phase 3

• Conditions: Health Condition 1: null- Uncomplicated Plasmodium falciparum malaria

• Registration Number: CTRI/2009/091/000315
• Lead Sponsor: Ipca Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 140

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adequate clinical and parasitological responseTimepoint: on day 42

Secondary Outcome Measures

Name	Time	Method
Fever clearance timeTimepoint: day 1,2,3;Parasite clearance timeTimepoint: Day 1,2,3