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Effectiveness of Oral Quinine and Artemether-Lumefantrine in the Treatment of Uncomplicated Malaria in Ugandan Children

NCT ID: NCT00540202

Last Updated: 2007-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-04-30

Brief Summary

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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

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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

Conditions

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Uncomplicated Malaria

Keywords

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Effectiveness Oral quinine Coartem Uncomplicated malaria Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1.Oral quinine

Patients will be given oral quinine at the dose of 10mg/kg 8 hourly for 7 days

Group Type EXPERIMENTAL

Oral quinine

Intervention Type DRUG

Quinine tablets given at 10mg/kg 8 hourly for 7 days

2. Coartem

Tablets

Group Type ACTIVE_COMPARATOR

artemether-lumefantrine

Intervention Type DRUG

Tablets taken twice daily for 3 days according to weight based guidelines.

Interventions

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artemether-lumefantrine

Tablets taken twice daily for 3 days according to weight based guidelines.

Intervention Type DRUG

Oral quinine

Quinine tablets given at 10mg/kg 8 hourly for 7 days

Intervention Type DRUG

Other Intervention Names

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Coartem

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Uganda

OTHER_GOV

Sponsor Role collaborator

Uganda Malaria Surveillance Project

OTHER

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role lead

Principal Investigators

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Ambrose O Talisuna, PhD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Uganda

Locations

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Mulago National Referral Hospital

Kampala, Central Region, Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Jane Achan, MMed

Role: CONTACT

Phone: +256-772-410183

Email: [email protected]

Daniel Kyabayinze, MSc

Role: CONTACT

Phone: +256-772-744066

Email: [email protected]

Facility Contacts

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Jane Achan, MMed

Role: primary

Catherine Maiteki, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 15569777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10770766 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19622553 (View on PubMed)

Other Identifiers

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QALE07

Identifier Type: -

Identifier Source: org_study_id