Status:
COMPLETED
Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine for Falciparum Malaria in Zanzibar, 2005
Lead Sponsor:
Professor Anders Björkman
Collaborating Sponsors:
Zanzibar Malaria Control Programme
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE4
Brief Summary
The primary objective of the study was to determine the PCR-APCR up to day 42 in children \<60 months of age, weighing ≥5kg with uncomplicated malaria, treated with either artesunate+ amodiaquine (ASA...
Detailed Description
All children in the right age group presenting with clinical signs of malaria at the study site were considered possible study subjects. The guardians of these children were informed about the study o...
Eligibility Criteria
Inclusion
- Weight ≥5kg
- No general danger signs or severe malaria present (see 4.4.2.1 \& 4.4.2.2)
- History of fever within 24 hours OR axillary temperature ≥ 37.5Cº
- No other cause of fever is detectable
- No severe malnutrition
- Patient has parasite counts between 2000-200,000/ul (50-5000/200 white blood cells)
- Guardian/Patient has understood the procedures of the study and is willing to participate
- Patient able to come for stipulated follow up visits and has easy access to the Study Site
Exclusion
- General Danger Signs and Complications:
- Not able to drink or breastfeed
- Vomiting everything
- Recent history of convulsions
- Lethargic or unconscious
- Unable to sit or stand (as appropriate for age)
- History of allergy to test drugs
- History of intake of any drugs other than paracetamol and aspirin within 3 days
- Signs of Severe Malaria:
- Altered consciousness
- Repeated convulsions
- Inability of oral intake
- Severe anaemia (Hb \<5gm/dl)
- Difficulty in breathing (pulmonary oedema, Respiratory Distress Syndrome)
- Shock (small pulse, cold extremities)
- Hypoglycaemia
- Haemoglobinuria (dark coloured urine or Coca-Cola urine)
- Kidney failure (little or no urine in a well-hydrated patient)
- Jaundice (yellow colouring of eyes)
- Hyperpyrexia (temperature above 39.5ºC) in combination with other signs
- Hyperparasitaemia (more than 5% red blood cells parasitized or \>200,000 parasites/µl)
- Spontaneous bleeding (Disseminated Intravascular Coagulation)
Key Trial Info
Start Date :
January 5 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2005
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT03768908
Start Date
January 5 2005
End Date
July 11 2005
Last Update
December 7 2018
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