Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria

Summary

This is a bi-centric phase IIIb, randomized, open label, 3-arm clinical trial performed to investigate the impact of retreatment with an Artemisinin-Based Combination (ACT), for example Arthemeter-Lumefantrine (AL) in Uganda (Ug) and artesunate-amodiaquine (ASAQ) in RDCongo, on malaria incidence and its potential selection of resistant strains.

Patients will be followed-up for efficacy and safety during 42 days after treatment with the first line therapy recommended by the national authorities(arthemeter-lumefantrine in Uganda and artesunate-amodiaquine in RDCongo) and retreated the patients either with the same ACT or an other ACT or oral Quinine + clyndamicin.

The investigators hypothesize that (re)treatment with the first line ACT treatment beyond 14 days is as efficacious as any other rescue treatment, without the risk of selecting drug resistant strains.

Conditions

• Malaria

Interventions

DRUG

Artemether/Lumefantrine

Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk). Weight in kg Number of tablet per dose Age 5 to \< 15 kg 1 tablet per dose 15 to \< 25 kg 2 tablets per dose 25 to \< 35 kg 3 tablets per dose

DRUG

Artesunate/Amodiaquine

Age (Weight in Kg) Dose Treatment duration 2 to 11 months (= 4,5 to \< 9kg):1 tablet (25 mg/675mg) for 3 days 1 to 5 years (= 9 kg to \< 18 kg)1 tablet(25mg/67,5mg)for 3 days

DRUG

Quinine + Clindamycin

this arm consist to 7 days treatment of 60 patients with quinine tablet 125mg + clindamycin syrup as follow; Quinine: 9 to \< 11 kg: ½ tablets 12 to \< 19 kg: 1 tablets per dose 20 to \< 27 kg: 1½ tablets per dose 28 to \< 35 kg: 2 tablets per dose Clindamycin syrup: 10 mg/kg twice daily

Sponsors & Collaborators

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Fund for Scientific Research, Flanders, Belgium

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• University of Kinshasa

  collaborator OTHER

• Centre Muraz

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Makerere University

  collaborator OTHER

• Universiteit Antwerpen

  lead OTHER

Principal Investigators

• Hypolite M. Mavoko, MD MPH · Kinshasa University, RDCongo

• Carolyn Nabasumba, M.B.Ch.B · Kazo health centre IV Uganda

• Jean-Pierre Van geertruyden, MD MPH PhD · International Health Unit Antwerp university

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• Republic of the Congo
• Uganda

Study Locations