Lymphatic filariasis and onchocerciasis
Conditions
Interventions
Sponsors
Kumasi Centre for Collaborative Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes (Lymphatic filariasis trial): To determine the: -Dead adult worms and MF assessed by the levels of CFA and MF 20 months after treatment onset (where day 0 is start of drug administration). -Absence of Wolbachia endobacteria in MF assessed by PCR 4 months after treatment onset Primary Outcomes (Onchocerciasis trial): To determine the: -Proportion of dead adult worms and MF assessed by immunohistology 20 months after treatment onset (where day 0 is start of drug administration). -Absence of Wolbachia endobacteria in adult female worms assessed by immunohistology 20 months after treatment onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes (Lymphatic filariasis trial): To determine the: - Reduction of Wolbachia bacteria in MF worms assessed by PCR 4, 12 and 18 months after treatment onset. - Absence of Wolbachia bacteria in MF worms assessed by PCR 4, 12 and 18 months after treatment onset. - Reduction of CFA in adult worms assessed by Alere filarial antigen test strips and TropBio ELISA 12 and 18 months after treatment onset. - Reduction of microfilariae in the blood 4, 12 and 18 months after treatment onset. - Absence of microfilariae in the blood at 4, 12 and 18 months after treatment onset. - Absence or reduction of filarial dance sign (FDS) detected by scrotal ultrasound 4, 12 and 18 months after treatment onset. - Adverse events (AEs) as well as serious adverse events (SAEs) in response to the different treatments will be assessed and described in the scope of the daily observed treatment (DOT). Secondary Outcomes (Onchocerciasis trial): • Assessment of embryogenesis in female worms by histology 20 months after treatment onset • Determination of number of nodules (onchocercomata) with free living microfilariae assessed by histology 20 months after treatment onset • Evaluation of worm embryogenesis assessed by histology 20 months after treatment onset a) Normal embryos b) Degenerated embryos c) no embryos (oocytes only or uterus empty • Assessment of number of live/ dead worms (macrofilaricidal activity) through histology 20 months after treatment onset • Insemination of female worms assessed by histology 20 months after treatment onset • Absence of Wolbachia bacteria (as a non-quantitative parameter) in adult worms assessed by immunohistology (using antisera against Wolbachia surface protein) as described for our previous trials [9] 20 months after treatment • Reduction of Wolbachia bacteria in adult worms assessed by immunohistology 20 months after treatment onset • Reduction of Wolbachia bacteria in adult worms assessed by PCR 20 months after treatment | — |
Countries
Ghana
Contacts
Public ContactJubin Osei Mensah
Project Manager
Outcome results
None listed