Malaria
Conditions
Interventions
Arterolane Maleate with Piperaquine Phosphate tablets
Artemether with Lumefantrine tablets
Sponsors
RANBAXY NIGERIA LTD. a SUN PHARMA company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients between the age of 12 to 65 years (both inclusive) 2. Body weight must be > 35 kg at screening 3. Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum parasites only; asexual parasite counts between 1,000 and 200,000 /µL blood will be included 4. Presence of fever (axillary temperature = 37.5 °C or oral = 38 °C) or a documented history of fever in the past 24 hours 5. Female patients of child-bearing potential must be non-lactating and willing to use effective contraceptive methods during the study period 6. Written informed consent, provided by patient in accordance with local practice. If a patient is unable to provide informed consent in writing, a thumbprint to indicate consent in the presence of at least one witness is acceptable. For adolescents written informed consent, in accordance with local practice, provided by parent/guardian. If the parent/guardian is unable to write, thumb print witnessed consent is permitted. For patients < 18 yrs, wherever feasible, assent will also be obtained 7. Willingness and ability to comply with the study protocol for the duration of the study Patient resides within a reasonable distance of the investigational site, so that attendance of all study visits and follow-up by medical staff are logistically feasible
Exclusion criteria
Exclusion criteria: 1. Signs of severe malaria or other danger signs, such as: a. Hyperparasitaemia >200,000 parasites/mL b. Altered consciousness c. Inability to sit or stand unsupported d. Severe anaemia (Hb £ 5 g/dL) e. Convulsions f. Shock (systolic BP 3 episodes of watery stools in the previous 24 hours or patients who have had 3 episodes of vomiting within 24 hours prior to screening). 9. Use of concomitant medications that may induce hemolysis or hemolytic anemia from the World Health Organization (WHO) list of essential drugs. 10. Any antimalarial treatment during 1 month prior to screening, as assessed by medical history. 11. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocystis carini pneumonia in children born to HIV+ women 12. Participation in any investigational drug study during 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the Day 28 Polymerase Chain Reaction (PCR) corrected Adequate Clinical and Parasitological Response (ACPR) of Synriam® and Coartem® tablets administered orally for 3 consecutive days in patients with acute uncomplicated P. falciparum malaria in Nigerian patients | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare PCR uncorrected ACPR on Day 28 of Synriam® and Coartem® tablets in Nigerian patients (key secondary objective) To compare the safety of Synriam® and Coartem® tablets in Nigerian patients To compare Parasite Clearance Time of Synriam® and Coartem® tablets in Nigerian patients To compare Fever Clearance Time of Synriam® and Coartem® tablets in Nigerian patients (key secondary objective) To compare PCR corrected ACPR on Day 42 of Synriam® and Coartem® tablets in Nigerian patients To compare PCR uncorrected ACPR on Day 42 of Synriam® and Coartem® tablets in Nigerian patients | — |
Countries
Nigeria
Contacts
Public ContactSameer Rao
Head Medical Affairs and Clinical Research Emerging Markets Sun Pharmaceutical Industries Limited
Outcome results
None listed