Cotrifazid Safety and Efficacy Against Malaria

Clinical Malaria Clinical Trial

Official title:

A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00322907
• Other study ID #: Fatol 1
• Status: Terminated
• Phase: Phase 2
• First received: May 5, 2006
• Last updated: May 5, 2006
• Start date: April 2000
• Est. completion date: January 2003

Study information

• Verified date: October 1999
• Source: Policlinique Médicale Universitaire
• Contact: n/a
• Is FDA regulated: No
• Health authority: Papua New Guinea: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 330
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clinical Malaria
• Malaria

Intervention

Drug:
• Cotrifazid vs mefloquine or quinine+SP

Locations

Country	Name	City	State
Papua New Guinea	Health centers	Madang and Maprik	Madang and East Sepik Province

Sponsors (3)

Lead Sponsor	Collaborator
Policlinique Médicale Universitaire	Papua New Guinea Institute of Medical Research, Swiss Tropical & Public Health Institute

Country where clinical trial is conducted

Papua New Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical treatment failure rate on day 14.
Primary	Incidence of adverse events.
Secondary	Parasitological failure rate on day 14
Secondary	Fever clearance time
Secondary	Parasite clearance time
Secondary	Symptoms clearance time
Secondary	Occurrence of complications