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Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238017
Recruitment Status : Unknown
Verified July 2005 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : October 13, 2005
Last Update Posted : February 2, 2006
University for Development Studies, Tamale, Ghana
Kintampo Health Research Centre, Ghana
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
The purpose of this study is to compare the efficacy and safety of two antimalarial drug regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with uncomplicated malaria. Also, genetic host factors which might influence efficacy and/or safety will be examined.

Condition or disease Intervention/treatment Phase
Malaria Drug: amodiaquine-artesunate versus amodiaquine Phase 4

Detailed Description:
Malaria remains a major cause of morbidity and mortality among children in sub-Saharan Africa. Current malaria control largely consists of rapid treatment of patients. Amodiaquine-artesunate and other combinatory treatment regimes including amodiaquine are now being introduced as first-line antimalarial drugs in several African countries. However, data on the efficacy and safety of amodiaquine and amodiaquine-artesunate are scarce. In addition, there is evidence that common genetic host factors, e.g. sickle cell trait, may influence efficacy and safety of these drugs. To examine efficacy and safety of the named drugs as well as a potential influence of genetic host factors on these outcomes a randomized, double blind trial among 400 children with uncomplicated malaria is performed in northern Ghana.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind Trial on the Efficacy and Safety of Amodiaquine-Artesunate and Amodiaquine Alone in the Treatment of Children With Uncomplicated Falciparum Malaria
Study Start Date : October 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  1. Parasitological and clinical cure rates by days 14 and 28
  2. Parasite and fever clearance times
  3. Carrier rates of sexual parasite stages at days 7, 14 and 28
  4. Incidence rates of adverse events

Secondary Outcome Measures :
  1. Incidence rate of haematological and biochemical evidence of drug-induced toxicity
  2. Primary endpoints in children with and without various genetic host factors

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female outpatients aged 6 to 59 months
  • Body weight >5 kg
  • Uncomplicated Plasmodium falciparum malaria
  • Mono-infection with P. falciparum with an asexual parasite density between 2,000 to 200,000 parasites/μl
  • Axillary temperature ≥37.5°C
  • Ability to tolerate oral therapy
  • Informed consent by the legal representative of the subject
  • Residence in study area

Exclusion Criteria:

  • Previous participation in this clinical trial
  • Haemoglobin <5 mg/dl
  • Mixed plasmodial infection
  • Danger signs (unable to drink; repeated vomiting; recent history of convulsions;lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO.
  • Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
  • Concomitant disease masking assessment of response
  • History of allergy or intolerance against study medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238017

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University for Development Studies
Tamale, Northern Region, Ghana
Sponsors and Collaborators
Charite University, Berlin, Germany
University for Development Studies, Tamale, Ghana
Kintampo Health Research Centre, Ghana
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Principal Investigator: Rowland N Otchwemah, PhD University for Development Studies
Principal Investigator: Frank P Mockenhaupt, MD Malaria Unit, Institute of Tropical Medicine, Charite University, Berlin, Germany
Principal Investigator: Seth Owusu-Agyei, PhD Kintampo Health Research Centre, Ghana

Layout table for additonal information Identifier: NCT00238017     History of Changes
Other Study ID Numbers: NP05-M4
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: February 2, 2006
Last Verified: July 2005

Keywords provided by Charite University, Berlin, Germany:
malaria, amodiaquine, artesunate, safety, efficacy

Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents