Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University for Development Studies, Tamale, Ghana
Kintampo Health Research Centre, Ghana
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00238017
First received: October 7, 2005
Last updated: February 1, 2006
Last verified: July 2005
  Purpose

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 Intervention Phase
Malaria
Drug: amodiaquine-artesunate versus amodiaquine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

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

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

Estimated Enrollment: 400
Study Start Date: October 2005
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238017

Locations
Ghana
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
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00238017     History of Changes
Other Study ID Numbers: NP05-M4, A50068
Study First Received: October 7, 2005
Last Updated: February 1, 2006
Health Authority: Ghana: Ministry of Health

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

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Artesunate
Artemisinins
Amodiaquine, artesunate drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides

ClinicalTrials.gov processed this record on July 22, 2014