Clinical trial NCT00322907: Cotrifazid Safety and Efficacy Against Malaria
Official title: A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Clinical Malaria
Keywords: malaria
treatment
cotrifazid
clinical trial
efficacy
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
Collaborators: name: Papua New Guinea Institute of Medical Research
name: Swiss Tropical & Public Health Institute
First posted: 2006-05-08
Enrollment: 330
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP)

Detailed description: Design: Open-label, block-randomised, comparative, multicentric trial. Setting: Four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea.

Participants: Patients of all ages with recurrent uncomplicated malaria Intervention: Random assignment to receive either Cotrifazid, mefloquine or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP).

Outcome measures: Incidence of clinical and laboratory adverse events; rate of clinical and/or parasitological failure at day 14

Eligibility criteria: Inclusion Criteria:

All subjects \> 6 months of age who presented at the centres and who were diagnosed with malaria (history of fever, OptiMAL® test positive, no other major symptom) and who had already been treated for malaria in the 28 days before, could be included in the study, if the subject or legal guardian (for children) gave informed consent and if the clinician in charge would have given the standard treatment for resistant malaria independent of the study -

Exclusion Criteria:

A subject was not to be included if the clinician preferred to use quinine for whatever reason, if the patient had one of the symptoms or signs of complicated or severe malaria (i.e. history of recent convulsion, any neurological sign or impairment of consciousness, heavy vomiting, haemoglobinuria, respiratory distress, bleeding, circulatory collapse, shock, jaundice, haemoglobin \< 5 g/dl), had contra-indications for mefloquine (history of psychiatric disorder, epilepsy), or was pregnant.

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Primary outcomes:
measure: Clinical treatment failure rate on day 14.
measure: Incidence of adverse events.
Secondary outcomes:
measure: Parasitological failure rate on day 14
measure: Fever clearance time
measure: Parasite clearance time
measure: Symptoms clearance time
measure: Occurrence of complications
Other outcomes:
Locations:
city: Madang and Maprik
country: Papua New Guinea
facility: Health centers
state: Madang and East Sepik Province
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Blaise Genton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: