Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00540202
Other study ID # QALE07
Secondary ID
Status Recruiting
Phase Phase 4
First received October 4, 2007
Last updated October 4, 2007
Start date September 2007
Est. completion date April 2008

Study information

Verified date October 2007
Source Makerere University
Contact Jane Achan, MMed
Phone +256-772-410183
Email achanj@yahoo.co.uk
Is FDA regulated No
Health authority Uganda: National Council for Science and Technology
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 302
Est. completion date April 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 5 Years
Eligibility 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

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 taken twice daily for 3 days according to weight based guidelines.
Oral quinine
Quinine tablets given at 10mg/kg 8 hourly for 7 days

Locations

Country Name City State
Uganda Mulago National Referral Hospital Kampala Central

Sponsors (3)

Lead Sponsor Collaborator
Makerere University Ministry of Health, Uganda, Uganda Malaria Surveillance Project

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 1. PCR adjusted parasitological cure rate on day 28. 2. Clinical cure rates on day 28. 28 days
Secondary 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. 28 days
See also
  Status Clinical Trial Phase
Completed NCT02787070 - A Randomized Controlled Trial on Malaria Primaquine Treatment in Timika, Indonesia (TRIPI) Phase 4
Completed NCT01213433 - Amodiaquine+Artesunate for Uncomplicated Malaria Treatment Phase 4
Active, not recruiting NCT00406146 - Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children Phase 3
Completed NCT05192265 - Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine Phase 2/Phase 3
Completed NCT04767191 - Malaria Therapeutic Efficacy Study (TES) Kenya Phase 4
Completed NCT04767217 - Malaria Therapeutic Efficacy Study, Rwanda Phase 4
Completed NCT06036030 - Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua Phase 2
Recruiting NCT06064591 - Host Immune and Metabolic Determinants of Sexual Conversion in Plasmodium Parasites IMMETASEX
Completed NCT06300970 - Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia Phase 4
Completed NCT00845533 - Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso Phase 4
Not yet recruiting NCT05911828 - A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers Phase 1
Completed NCT03387631 - Efficacy And Safety Of AL For The Treatment Of Uncomplicated Falciparum Malaria In Mainland Tanzania N/A
Completed NCT00868465 - Treatment Efficacy and Malaria TRANSmission After Artemisinin Combination Therapy (TRANSACT) N/A
Completed NCT00460369 - Treatment of Uncomplicated Malaria in Benin N/A
Completed NCT00459615 - Phase II Dose Ranging Study of Artesunate Phase 2