Clinical trial NCT00540202: Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
Official title: Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Uncomplicated Malaria
Keywords: Effectiveness
Oral quinine
Coartem
Uncomplicated malaria
Children
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Uganda
name: Uganda Malaria Surveillance Project
First posted: 2007-10-05
Enrollment: 302
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will test the hypothesis that there is a difference in effectiveness of oral quinine in comparison to artemether Lumefantrine in the treatment of uncomplicated malaria in children.

Detailed description: This study will be designed as an open randomized effectiveness study assessing the parasitological and clinical cure rates and adherence to oral quinine monotherapy in comparison to artemether-Lumefantrine. We will also describe some of the adverse events to the two drugs.The measurements will include age, sex, weight, hemoglobin levels on days 0, 7, 14 and 28, parasite density on days 0, 7, 14 and 28 and clinical examination findings. Adverse events will also be documented

Eligibility criteria: Inclusion Criteria:

1. Aged between 6 and 59 months of age seen at the assessment centre during the study period
2. With fever defined as axillary temperature ≥37.5 °C or history of fever in the past 24 h
3. With a microscopically confirmed monoinfection of Plasmodium falciparum
4. Able to tolerate oral therapy,
5. Whose parents/guardians have provided written informed consent.

Exclusion Criteria:

1. Children with a history of allergy to quinine, artemether-Lumefantrine or milk.
2. Evidence of severe malaria.
3. Residence at more than 20km from the health clinic.
4. Evidence of a significant concomitant febrile illness that would require hospitalization or chronic medical illness

Primary outcomes:
measure: 1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28.
timeFrame: 28 days
Secondary outcomes:
measure: 1. Fever clearance time assessed by self report. 2. Hemoglobin changes on day 0, 7, 14 and 28. 3. Safety profiles. 4. Adherence: measured by patient report and pill count on day 3 for the artemether-Lumefantrine group and day 7 for the quinine group.
timeFrame: 28 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago National Referral Hospital
state: Central
Study officials:
affiliation: Ministry of Health, Uganda
name: Ambrose O Talisuna, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fogg C, Bajunirwe F, Piola P, Biraro S, Checchi F, Kiguli J, Namiiro P, Musabe J, Kyomugisha A, Guthmann JP. Adherence to a six-dose regimen of artemether-lumefantrine for treatment of uncomplicated Plasmodium falciparum malaria in Uganda. Am J Trop Med Hyg. 2004 Nov;71(5):525-30.
citation: de Vries PJ, Bich NN, Van Thien H, Hung LN, Anh TK, Kager PA, Heisterkamp SH. Combinations of artemisinin and quinine for uncomplicated falciparum malaria: efficacy and pharmacodynamics. Antimicrob Agents Chemother. 2000 May;44(5):1302-8. doi: 10.1128/AAC.44.5.1302-1308.2000.
citation: Achan J, Tibenderana JK, Kyabayinze D, Wabwire Mangen F, Kamya MR, Dorsey G, D'Alessandro U, Rosenthal PJ, Talisuna AO. Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial. BMJ. 2009 Jul 21;339:b2763. doi: 10.1136/bmj.b2763.