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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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artesunate + amodiaquine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anders Björkman, Professor

Role: STUDY_DIRECTOR

Karolinska UH

Guida Rotlland, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Karolinska UH

Locations

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Kivunge Cottage Hospital

Kivunge, North A District, Zanzibar, Tanzania

Site Status

Countries

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Tanzania

Other Identifiers

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ACOIII

Identifier Type: -

Identifier Source: org_study_id