A Phase 4, Open Label, Randomized Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Arterolane Maleate–Piperaquine Phosphate Tablets in Comparison to Artemether–Lumefantrine Tablets for the Treatment of uncomplicated falciparum Malaria in Adolescent and Adult Patients in Nigeria

Phase 4

• Conditions: Malaria

• Registration Number: PACTR202305878745601
• Lead Sponsor: RANBAXY NIGERIA LTD. a SUN PHARMA company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 250

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

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 < 50 mmHg, and or presence of cold clammy extremities, fast, low-volumepulses)
g. Evidence of acidosis (deep and fast breathing)
h. Inability to drink or breastfeed
i. Vomiting everything
j. Disseminated intravascular coagulation (DIC)
k. Jaundice
l. Hypoglycemia
2. Severe malnutrition
3. History of allergy to test drugs
4. Concomitant febrile condition(s) due to diseases other than malaria (e.g., measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g., cardiac, renal or hepatic diseases)
5. Mixed infection with another Plasmodium species at the time of presentation (including P. vivax, P. ovale and P. malariae)
6. A female patient who is lactating or pregnant at screening
7. Known allergy to artesunate, artemether, artemisinin derived products, lumefantrine, piperaquine or any other related drug
8. Gastrointestinal dysfunction that could alter absorption or motility (e.g., diarrhea defined as > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified