drugset / Trial / NCT04020653
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a pilot, double-blind, randomized, parallel-group, placebo-control, exploratory study to evaluate the efficacy and safety of 5-aminolevulinic acid hydrochloride (5-ALA HCl) and sodium ferrous citrate (SFC) added on artemisinin-based combination therapy (ACT) compared with ACT alone in the treatment of malaria. Patients who are suffering from uncomplicated malaria, are eligible for randomization.The study will be conducted in a total of 75 patients with uncomplicated malaria.
Timeline
- Start
- 2019-09-06
- Primary completion
- 2020-05-31
- Completion
- 2020-09-30
Outcome
Outcome not reported
Stopped: “Considering the Thai FDA requirement, changes of Malaria cases in Thailand and EC recommendation, the decision to withdrawal the study was made.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 300 mg | — |
| Subject | Aminolevulinic Acid | Diagnostic / imaging agent | 600 mg | — |
| Subject | Sodium ferrous citrate | Small molecule | 236 mg | — |
| Subject | Sodium ferrous citrate | Small molecule | 472 mg | — |
| Background | Artemether | Small molecule | 20 mg | — |
| Background | lumefantrine | Small molecule | 120 mg | — |