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Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction in Zanzibar

This study has suspended participant recruitment.
(Due to lack of malaria patients in Zanzibar the study has been suspended.)
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00465257
First received: April 23, 2007
Last updated: May 16, 2008
Last verified: May 2008
History of Changes
  Purpose

The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.


Condition Intervention Phase
Malaria
 Drug: artesunate + amodiaquine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • PCR adjusted parasitological cure rate by day 42.

Estimated Enrollment: 110
Study Start Date: May 2007
  Eligibility

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

Inclusion Criteria:

  • Age below 60 months
  • Weight ≥5kg
  • No general danger signs or severe malaria present (see 4.4.2.1 & 4.4.2.2)
  • History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
  • No other cause of fever is detectable
  • No severe malnutrition
  • Presence of P. falciparum asexual parasite density between 2000- 200,000/ul
  • Guardian/Patient has understood the procedures of the study and is willing to participate
  • Patient able to come for stipulated follow up visits and has easy access to the Study Site

Exclusion Criteria:

  • Not able to drink or breastfeed
  • Persistent Vomiting
  • Recent history of convulsions
  • Lethargic or unconscious
  • Unable to sit or stand (as appropriate for age)
  • History of allergy to test drugs
  • History of intake of any drugs other than paracetamol and aspirin within 3 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465257

Locations
Tanzania
Kivunge Cottage Hospital
Kivunge, North A District, Zanzibar, Tanzania
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Study Director: Anders Björkman, Professor Karolinska UH
Principal Investigator: Guida Rotlland, MD, MPH Karolinska UH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00465257     History of Changes
Other Study ID Numbers: ACOIII
Study First Received: April 23, 2007
Last Updated: May 16, 2008
Health Authority: Tanzania: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013