Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

NCT00699920 | Completed Phase 4

• 1 other identifier: ARAMF_L_02661
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient. Secondary objectives: For the first attack: To compare the 2 groups of treatment in terms of:

• Day 42 efficacy
• Parasitological and fever clearance
• Clinical and Biological tolerability
• Evolution of gametocyte carriage For attack 2nd and following: To compare the 2 groups of treatment in terms of:
• Day 28 and Day 42 clinical and parasitological effectiveness
• Clinical and Biological tolerability
• Proportion of patients without fever at Day 3
• Proportion of patients without parasites at Day 3
• Evolution of gametocyte carriage
• Compliance During the total follow up of the cohort: To compare the 2 groups of treatment in terms of:
• Treatment incidence density
• Impact of repeated treatment on clinical and biological tolerability
• Impact on anaemia
• Impact on Hackett score.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• PCR corrected and uncorrected clinical and parasitological cure rate

  At Day 28

Secondary Outcomes (9)

• Fever and parasitological clearance evaluation by measuring the axillary temperature and monitoring paratesimia

  At the first attack

• Proportion of afebrile patients and proportion of patients without parasites

  At Day 3 (following attacks)

• Evolution of baseline symptoms (Clinical efficacy measure)

  During the study conduct

• Number of residual tablets in blisters (compliance)

  At the end of the study treatment

• Treatment incidence density: comparison of the number of malaria attacks between the 2 arms

  During the 2 years of follow-up

Study Arms (2)

1

EXPERIMENTAL

Coarsucam double-layer artesunate/amiodaquine tablets

Drug: Coarsucam

2

ACTIVE COMPARATOR

Coartem (artemether/lumefantrine) fixed-dose combination tablets

Drug: Coartem

Interventions

Coarsucam DRUG

Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days

1

Coartem DRUG

Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days

2

Eligibility Criteria

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

You may qualify if:

• Confirmed mono infection with Plasmodium falciparum, with parasite density ≥2000 asexual forms per µl of blood,
• Body weight ≥5 kg
• Able to be treated by oral route
• Fever (axillary temperatur ≥37.5 degrees Celsius) at D0 or history of fever within the previous 24 hours
• Confirmed Plasmodium falciparum infection with positive paratesimia
• Haemoglobin value ≥5.0 g/dl

You may not qualify if:

• Patient participating in another ongoing clinical trial
• Allergy to one of the investigational medicinal products
• History of hepatic and (or) haematological impairment during treatment with amodiaquine
• History of cardiac disease
• Concomitant febrile illness
• Presence of at least one danger sign of malaria: recent history of convulsions (1-2 within 24h), unconsciousness state, lethargy, unable to drink or breast feed, vomiting everything, unable to stand/sit due to weakness
• Severe concomitant disease or known disturbances of electrolyte balance such as hypokalaemia or hypomagnesaemia
• Patient having received artesunate + amiodaquine or artemether + lumefantrine at suitable dosage within the previous 2 weeks.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-aventis administrative office

Kampala, Uganda

Location

Related Publications (1)

• Yeka A, Lameyre V, Afizi K, Fredrick M, Lukwago R, Kamya MR, Talisuna AO. Efficacy and safety of fixed-dose artesunate-amodiaquine vs. artemether-lumefantrine for repeated treatment of uncomplicated malaria in Ugandan children. PLoS One. 2014 Dec 1;9(12):e113311. doi: 10.1371/journal.pone.0113311. eCollection 2014.

  PMID: 25436614 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Valerie Lemeyre

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 18, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

UG (1)