Health Condition 1: B509- Plasmodium falciparum malaria, unspecified
Conditions
Interventions
Intervention1: 5-aminolevulinic acid hydrochloride (5-ALA-HCl) and Sodium Ferrous Citrate (SFC): Arm 2: 5-ALA-HCl 300mg/day + SFC 236mg/day-Capsule_Oral dose
Arm 3: 5-ALA-HCl 600mg/day + SFC 472mg/day
Sponsors
Neopharma Japan Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Weighing 40 to 90 kg 2. Women with child bearing potential willing to give consent for pregnancy test. 3.Patients and spouse/partner who is of childbearing potential must be using 2 acceptable methods of contraception one of which must be a physical barrier method, (eg. Spermicidal gel plus condom; condom plus partner is sterilized at least 6 months prior) for the entire study duration. 4. Presence of symptomatic uncomplicated P. falciparum with a diagnosis confirmed by: microscopically confirmed parasite infection, between 1000 and 100,000 asexual parasite count/μl of blood fever, as defined by axillary/tympanic of >= 37.5°C or oral/rectal/temperature of >= 38.0°C, or history of fever within previous 24 hours (must be documented) 5. Patients must be willing and able to give written informed consent and comply with all study visits and procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2010 2. Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the trial or inability to tolerate oral treatment 3. Presence of febrile conditions caused by diseases other than malaria 4. Known history of photo-hypersensitivity, porphyria, or hemochromatosis 5. Have taken any medication with antimalarial or antibiotic with antimalarial effect in previous 14 days 6. Received an investigational drug within the past 4 weeks 7. Patients whose Hb level is lower than 8 g/dL 8. Liver function tests [AST/ALT levels] more than 2.5 times upper limit of normal values 9. Known significant renal impairment as indicated by serum creatinine of >= 1.4 mg/dL or eGFR of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Cure rate on Day 28 [Time Frame: 28 days since the start of definitive oral antimalarial therapy] defined as the proportion of patients with PCR-corrected Adequate Clinical and Parasitological Response (ACPR). 2.Safety [Time Frame: 42 days since the start of definitive oral antimalarial therapy] Incidence of any adverse event. Timepoint: 1st Time Point: On day 28 2nd Time Point: On day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cure rate on Day 14 [Time Frame: 14 days] 2. Parasite Clearance [Time Frame: 28 days] 3. Fever Clearance 4. Gametocyte Clearance Time [Time Frame:28 days] 5. Gametocyte Carriage Over Time [Time Frame: 28 days] 6. Change in inflammatory parameters [Time Frame: 14 days] 7. Change in iron metabolism [Time Frame: 14 days] 8. Change in immunological parameters [Time Frame: 14 days] 9. Detection of anti-malaria antibody [Time Frame: 42 days]Timepoint: 1. Cure rate on Day 14 [Time Frame: 14 days] 2. Parasite Clearance [Time Frame: 28 days] 3. Fever Clearance 4. Gametocyte Clearance Time [Time Frame:28 days] 5. Gametocyte Carriage Over Time [Time Frame: 28 days] 6. Change in inflammatory parameters [Time Frame: 14 days] 7. Change in iron metabolism [Time Frame: 14 days] 8. Change in immunological parameters [Time Frame: 14 days] 9. Detection of anti-malaria antibody [Time Frame: 42 days] | — |
Countries
India
Contacts
Public ContactPraveen Kumar Parepally
ClinSync Clinical Research Pvt. Ltd
Outcome results
None listed