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
  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:


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
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: 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
Protozoan Infections
Parasitic Diseases
Artesunate
Amodiaquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials

ClinicalTrials.gov processed this record on October 19, 2014