PACTR202305878745601
Not yet recruiting
Phase 4
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
RANBAXY NIGERIA LTD. a SUN PHARMA company0 sites250 target enrollmentMay 16, 2023
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- RANBAXY NIGERIA LTD. a SUN PHARMA company
- Enrollment
- 250
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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