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

NCT00465257 | Suspended Phase 4

• 1 other identifier: ACOIII
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• PCR adjusted parasitological cure rate by day 42.

Interventions

artesunate + amodiaquine DRUG

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Kivunge Cottage Hospital

Kivunge, North A District, Zanzibar, Tanzania

Location

MeSH Terms

Conditions

Malaria

Interventions

amodiaquine, artesunate drug combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Anders Björkman, Professor

  Karolinska UH

  STUDY DIRECTOR

• Guida Rotlland, MD, MPH

  Karolinska UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: May 1, 2007
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

TA (1)