Malaria, Falciparum Clinical Trial
Official title:
Phase IIa Exploratory, Open Label, Single/Multiple Dose Testing Clinical Study to Assess the Preliminary Efficacy, Tolerability and PK of OZ439 in Adult Patients With Acute, Uncomplicated P. Falciparum or Vivax Malaria Mono-infection
Verified date | November 2014 |
Source | Medicines for Malaria Venture |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Food and Drug Administration |
Study type | Interventional |
A Phase IIa Exploratory, Open label, Single Dose Regimen, Multiple Dose Testing Clinical Study to Assess the Preliminary Efficacy, Tolerability and Pharmacokinetics of OZ439 in adult patients with acute, uncomplicated Plasmodium falciparum or vivax malaria mono-infection.
Status | Completed |
Enrollment | 82 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Male or female patients between the age of 18 and 60 years, inclusive 2. Body weight between 40 kg and 90 kg inclusive 3. Presence of mono-infection of P. falciparum or P. vivax confirmed by: - Fever, as defined by axillary temperature = 37.5°C or oral/rectal/tympanic temperature = 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and, - Microscopically confirmed parasite infection, 5,000 to 50,000 asexual parasite count/µl of blood 4. Written informed consent, in accordance with local practice, provided by patient. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations 5. Ability to swallow oral medication 6. Ability and willingness to participate and access the health facility 7. Agree to minimum of 4 days hospitalisation for drug administration and pharmacokinetic sampling Exclusion Criteria: 1. Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organisation Criteria 2010 (Attachment 2) 2. Mixed Plasmodium infection 3. Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment, or severe diarrhoea defined as 3 or more watery stools per day 4. Presence of other serious or chronic clinical condition requiring hospitalisation. 5. Severe malnutrition (defined as the weight-for-height being below -3 standard deviation or less than 70% of median of the NCHS/WHO normalised reference values). 6. Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval greater than or equal to 450 msec), respiratory (including active tuberculosis), history of jaundice, hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions or other abnormality (including head trauma). 7. Known history of hypersensitivity, allergic or adverse reactions to artemisinin containing compounds or mefloquine or drug in the national guidelines for P. vivax. 8. Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab). 9. Have received any antimalarial treatment in the preceding 14 days, as determined by history and screening test. 10. Have received antibacterial with known antimalarial activity in the preceding 14 days. 11. Have received an investigational drug within the past 4 weeks. 12. Liver function tests (ASAT/ALAT levels) more than 2 x ULN 13. Hb level below 10 g/dL. 14. Bilirubin levels greater than 40 µmol/L. 15. Serum creatinine levels more than 2 times the upper limit of normal range in absence of dehydration. In case of important dehydration the creatinine should be lower than 2X ULN after oral/parenteral rehydration. 16. Female patients must be neither pregnant (as demonstrated by a negative serum pregnancy test) nor lactating, and must be willing to take measures not to become pregnant during the study period and safety follow-up period |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medicines for Malaria Venture | Mahidol University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Derived Parasite Reduction Rate at 24 Hours (PPR24) | PRR24 is the log10 change in parasitemia over 24 hours estimated from a regression model fit separately for each patient. The relationship between parasite counts and time was analyzed by fitting a variable lag phase, then a linear decline to the natural log of parasite count versus time relationship. The slope of this log linear relationship is the primary end-point. The time points chosen for the regression are those that yield the highest degree of significance when assessing the regression when the number of time points are greater than or equal to 3. No extrapolation was performed. |
24 hours after study drug administration | No |
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