Tolerability and Efficacy of CD+A Compared to AQ+SP for the Treatment of P.Falciparum Malaria in Rwandan Children

NCT00461578 | Completed

• 1 other identifier: CDA/RWD/2006
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up until day 28 after treatment. Adverse events, clinical and parasitological outcomes were recorded.

Conditions

Malaria

Keywords

P.falciparum; malaria; lapdap+artesunate; safety; efficay

Outcome Measures

Primary Outcomes (1)

• Incidence of microscopically and genotypically confirmed recrudescent infections in the different treatment groups by day 28

Secondary Outcomes (3)

• Parasite clearance

• Fever clearance

• Occurrence of adverse events

Interventions

Chlorproguanil-dapsone + artesunate DRUG

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 12-59 months;
• Weight ≥5 kg;
• Monoinfection with P. falciparum;
• Parasite density between 2,000-200,000/µL;
• Fever (axillary body temperature =\>37.5C) or history of fever in the preceding 24 hours;
• Packed Cell Volume (PCV) \>21%.

You may not qualify if:

• Severe malaria;
• Mixed malaria infection;
• Any other concomitant illness or underlying disease;
• Known allergy to the study drugs being used in this trial;
• Clear history of adequate antimalarial treatment in the previous 72 hours.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Institute of Tropical Medicine, Belgium: collaborator

Study Sites (1)

Programme Nationale Integre de Lutte contre le Paludisme

Kigali, BP 2514, Rwanda

Location

Related Publications (2)

• Fanello CI, Karema C, Avellino P, Bancone G, Uwimana A, Lee SJ, d'Alessandro U, Modiano D. High risk of severe anaemia after chlorproguanil-dapsone+artesunate antimalarial treatment in patients with G6PD (A-) deficiency. PLoS One. 2008;3(12):e4031. doi: 10.1371/journal.pone.0004031. Epub 2008 Dec 29.

  PMID: 19112496 DERIVED

• Fanello CI, Karema C, Ngamije D, Uwimana A, Ndahindwa V, Van Overmeir C, Van Doren W, Curtis J, D'Alessandro U. A randomised trial to assess the efficacy and safety of chlorproguanil/dapsone + artesunate for the treatment of uncomplicated Plasmodium falciparum malaria. Trans R Soc Trop Med Hyg. 2008 May;102(5):412-20. doi: 10.1016/j.trstmh.2008.01.013. Epub 2008 Mar 6.

  PMID: 18328518 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

chloroguanil, dapsone drug combination; Artesunate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Umberto d'Alessandro, MD

  ITM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: April 1, 2005
• Study Completion: October 1, 2006
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

RW (1)