We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00465257
First Posted: April 24, 2007
Last Update Posted: May 20, 2008
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.
Information provided by:
Karolinska University Hospital
  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
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00465257     History of Changes
Other Study ID Numbers: ACOIII
First Submitted: April 23, 2007
First Posted: April 24, 2007
Last Update Posted: May 20, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Amodiaquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials