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

This study has been suspended.

Sponsored by:	Karolinska University Hospital
Information provided by:	Karolinska University Hospital
ClinicalTrials.gov Identifier:	NCT00465257

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 IV

MedlinePlus related topics: Malaria

Drug Information available for: Artesunate Amodiaquine Amodiaquine hydrochloride

U.S. FDA Resources

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

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, North A District, Zanzibar
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

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

Study placed in the following topic categories:

Artesunate
Protozoan Infections
Amodiaquine

Parasitic Diseases
Malaria
Malaria, Falciparum

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

Coccidiosis
Therapeutic Uses
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009