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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00529867
Other study ID # SSC protocol No. 1210
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2007
Last updated January 17, 2008
Start date May 2007
Est. completion date December 2007

Study information

Verified date January 2008
Source Dafra Pharma
Contact n/a
Is FDA regulated No
Health authority Kenya: Ethical Review CommitteeKenya: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya


Recruitment information / eligibility

Status Completed
Enrollment 267
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 59 Months
Eligibility Inclusion Criteria:

- Children aged between 6 and 59 months

- Minimum body weight of 5kg

- Presence of fever (Temp >/= 37.5°C) or a history of fever in the last 24 hours

- Presence of asexual P. falciparum monoinfection

- Initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood

- Not suffering from severe and complicated forms of malaria

- Able to take drugs under study by the oral route

- Parent or guardian gives informed written consent to participate in study

Exclusion Criteria:

- Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb =/<5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (>200,000 µl)

- Patients treated with mefloquine, halofantrine within the 7 days before Day 0 or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0

- Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria

- Patients with vomiting and/or diarrhoea

- Signs of severe malnutrition (defined as follows: children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)

- Presence of general danger signs in children below 5 years or other signs of serious and complex Plasmodium falciparum, as stated in the present WHO definitions

- Patients with known history of heart disease or arrhythmia

- History of allergy to artemether/lumefantrine or quinine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Artemether/lumefantrine tablets
Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2
Artemether/Lumefantrine suspension
Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2

Locations

Country Name City State
Kenya Chulaimbo Health Centre Kisumu Nyanza

Sponsors (2)

Lead Sponsor Collaborator
Dafra Pharma Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare PCR corrected cure-rates on day 14 and 28 1 year
Secondary To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28 28 days
Secondary To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28 28 days
Secondary Monitor any possible adverse reactions following use of both drugs 28 days
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