Anti-Malarial Drug Resistance in Cameroon

NCT00146718 | Completed Phase 2

• 1 other identifier: ITDCVG34
• Study Type: interventional
• Target: 755
• Locations: 0 countries
• Sites: N/A

Brief Summary

The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. In addition, drug resistance will be determined by measurement of blood drug levels,and identification of molecular markers of resistance.

Conditions

Malaria

Keywords

malaria; drug resistance; antimalarials

Outcome Measures

Primary Outcomes (1)

• Adequate clinical and parasitological response(ACPR) on Day 28

Secondary Outcomes (3)

• ACPR Day 14

• Early treatment failure, between days 1 and 3

• Late treatment failure, between days 4 and 14

Interventions

Amodiaquine and Sulphadoxine/Pyrimethamine DRUG

Eligibility Criteria

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

You may qualify if:

• Children 6-59 months of age
• Recorded temperature between 37.5oC and 39.5 oC
• Signs/symptoms of acute uncomplicated P. falciparum malaria.
• Positive microscopy for mono-infection with P falciparum malaria
• Asexual blood stage parasitaemia in the range 1,000 to 100,000 asexual parasites per ul
• Consent from parent or guardian of a child.
• No other apparent cause for the child's illness.

You may not qualify if:

• Presence of signs of severe complicated falciparum malaria.
• Cerebral malaria (unrousable coma)
• Vomiting \> twice within preceding 24 hours
• More than one convulsion within preceding 24 hours
• Inability to drink or breast-feed, or to take oral medication
• Haemoglobin less than 5g/dl or a hematocrit of less than 15%.
• Documented evidence of adequate treatment with drugs expected to be effective in the preceding 72 hours
• Presence of underlying diseases (cardiac, renal, hepatic,malnutrition, gastrointestinal)
• History of allergy to study drug
• Inability to attend for the stipulated follow-up visits,
• Difficulty in accessing the health facility, or any situation or condition which may compromise the patients ability to comply with the trial procedures.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University of Yaounde: collaborator

MeSH Terms

Conditions

Malaria

Interventions

Amodiaquine; Sulfadoxine; Pyrimethamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Wilfred Mbacham, ScD

  Laboratory for Public Health Biotechnology, University of Yaounde I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2005
• First Posted: September 7, 2005
• Study Start: August 1, 2003
• Study Completion: May 1, 2005
• Last Updated: January 12, 2017

Record last verified: 2017-01