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

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: NCT00465257
Recruitment Status : Suspended (Due to lack of malaria patients in Zanzibar the study has been suspended.)
First Posted : April 24, 2007
Last Update Posted : May 20, 2008
Information provided by:
Karolinska University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Malaria Drug: artesunate + amodiaquine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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

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:

  • Age below 60 months
  • Weight ≥5kg
  • No general danger signs or severe malaria present (see &
  • 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

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): NCT00465257

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Kivunge Cottage Hospital
Kivunge, North A District, Zanzibar, Tanzania
Sponsors and Collaborators
Karolinska University Hospital
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Study Director: Anders Björkman, Professor Karolinska UH
Principal Investigator: Guida Rotlland, MD, MPH Karolinska UH
Layout table for additonal information Identifier: NCT00465257    
Other Study ID Numbers: ACOIII
First Posted: April 24, 2007    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008
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