The efficacy of Rifampicin 35mg/Kg/d plus Albendazole 400mg/d given for 7 or 14 days against Lymphatic Filariasis and Onchocerciasis– a randomized, controlled, parallel-group, open-label, phase II pilot trial

Kumasi Centre for Collaborative Research0 个研究点目标入组 240 人开始时间: 2020年7月13日最近更新: 2023年5月29日

试验速览

暂无简介。

•Lymphatic filariasis
•Participants will only be included in the study if they meet all of the following criteria:
•Willingness to participate in the study by signing the Informed Consent Form (ICF)
•18-55 years
•Body weight > 45kg
•Positive for CFA detected by Fliarial Test Strip (FTS) and with or without filarial dance sign (FDS) detected by Ultrasonography (USG) measurement
•MF-positive
•Good general health without any clinical condition requiring medication
•No previous history of tuberculosis
•Participants with the ability to follow study instructions and who are likely to attend and complete all required visits
•Onchocerciasis
•Participants will only be included in the study if they meet all of the following criteria:
•Willingness to participate in the study by signing the Informed Consent Form (ICF)
•18-55 years
•Body weight > 45kg
•Presence of at least 1 medium-sized onchocercoma detected by palpation
•MF-positive
•Good general health without any clinical condition requiring medication
•No previous history of tuberculosis
•Participants with the ability to follow study instructions and are likely to attend and complete all required visits

•General Exclusion Criteria:
•Participants not able to give consent
•Participants who are unable to understand the nature, scope, significance and consequences of this clinical trial
•Participants taking concomitant medication that interferes with study drugs (at the discretion of trial clinician)
•Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure (rifampicin or any member of the rifamycins)
•Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
•Participants with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
•Known or persistent abuse of medication, drugs or alcohol
•Laboratory Exclusion Criteria:
•Evidence of clinically significant neurological, cardiac, pulmonary, hepatic or renal disease as far as can be assessed by history of participants, physical examination, and/or laboratory examinations
•Evidence of acute Hepatitis A and acute or chronic Hepatitis B or C
•Laboratory evidence of liver disease (AST, ALT and ?GT greater than 1.5 times the upper limit of normal
•Laboratory evidence of renal disease (eGRF <60ml/min/1.732M2)
•Laboratory evidence of leukopenia (leukocytes < lower limit of normal)

发起方

Kumasi Centre for Collaborative Research