PER-044-14Completed未知
A PROOF-OF-CONCEPT, OPEN LABEL STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE DOSES OF DSM265 IN ADULT PATIENTS WITH ACUTE, UNCOMPLICATED PLASMODIUM FALCIPARUM OR VIVAX MALARIA MONO-INFECTION OVER A 28-DAY-EXTENDED OBSERVATION PERIOD
MMV Medicines for Malaria Venture,0 sites45 target enrollmentStarted: September 26, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 60 (—)
Inclusion Criteria
- •Patients must fulfil the following inclusion criteria to be eligible for enrolment in the study:
- •1. Male or female patients between the ages of 18 and 60 years, inclusive
- •2. Body weight between 45 kg and 90 kg inclusive
- •3. Presence of mono-infection of P. falciparum or P. vivax confirmed by:
- •a. 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,
- •b. Microscopically confirmed parasite infection: 1,000 to 35,000 asexual parasite count/μL 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
- •Ability and willingness to participate and to comply with the study requirements
- •7. Agree to hospitalisation for at least 72 hours and until malarial parasites are not detected by microscopy on 2 consecutive occasions
- •8. Agree to come back to the hospital on Day 5 (in addition to the other study days), if by Day 3 malarial parasites have not fallen below the level of PCR detection on at least two consecutive occasions (at time points 66h and 72h). If there are no longer any signs or symptoms of malaria then to be available every 3-4 days for blood sampling for microscopy and qPCR, and re-hospitalisation for SOC treatment in the event of qPCR levels being detectable (Attachment 6)
Exclusion Criteria
- •To be eligible for enrolment in the study, patients must NOT meet any of the following criteria:
- •1. Patients with signs and symptoms of severe / complicated malaria according to the World Health Organisation Criteria 2010 (Attachment 1: Definition of Severe Malaria)
- •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, QTcF interval greater than or equal to 450 msec, personal or family history of long QT syndrome, PR interval >200msec; any relevant intra-ventricular heart block [QRS>120msec]), respiratory (including active tuberculosis), history of jaundice, hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine including any type of diabetes mellitus whether controlled or not, diabetes insipidus, uncontrolled hypo- or hyperthyroidism, endocrine reproductive disorders not requiring concurrent medication, disorders of adrenal function, infectious conditions other than minor skin or soft tissue infections or confirmed minor lower urinary tract infection, malignancy, psychiatric, history of convulsions or other neurological or psychiatric abnormality (including head trauma); any other disorder or condition that in the opinion of the investigator may render the subject
- •unfit for participation or place him/her at increased risk if he/she participates in the study.
- •7. Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
- •8. Have received any antimalarial treatment in the past:
- • With a piperaquine-based compound, mefloquine, naphthoquine or sulphadoxine / pyrimethamine within the previous 6 weeks
- • With amodiaquine or chloroquine within the previous 4 weeks
- • With quinine, halofantrine, lumefantrine-based compounds and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 14 days
- • With any herbal products or traditional medicines, within the past 7 days
- •9. Have received antibacterial treatment with known antimalarial activity in the preceding 14 days
- •10. Have received an investigational drug within the 4 weeks prior to screening
- •11. (a) AST/ALT ≥2 the upper limit of normal range (ULN) and total bilirubin is normal
- •(b) AST/ALT >1.5 ULN and total bilirubin is >1 and ≤1.5 ULN
- •12. Hb level = <8g/dL
- •13. Total bilirubin >1.5 ULN
- •14. Serum creatinine levels >2 ULN
- •15. Female patients must be neither lactating nor pregnant as demonstrated by a negative urine point-of-care pregnancy test at screening and serum point-of-care pregnancy test pre-dose (the result of the pre-dose assessment must be confirmed negative prior to dosing), and must be willing to take measures not to become pregnant during the stu
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