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

Malaria Clinical Trial

Official title:

Efficacy of Artesunate + Amodiaquine Four Years After Its Introduction as New Treatment Policy for Uncomplicated Plasmodium Falciparum Malaria in Zanzibar

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00465257
• Other study ID #: ACOIII
• Status: Suspended
• Phase: Phase 4
• First received: April 23, 2007
• Last updated: May 16, 2008
• Start date: May 2007

Study information

• Verified date: May 2008
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 110
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• artesunate + amodiaquine

Locations

Country	Name	City	State
Tanzania	Kivunge Cottage Hospital	Kivunge	North A District, Zanzibar

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCR adjusted parasitological cure rate by day 42.