Lymphatic filariasis (Wuchereria bancrofti) Infections and Infestations Filariasis
Conditions
Interventions
The participants are randomised and assigned to one of the following seven treatment regimens:
Treatment regimen 1 (n = 65):
4 weeks doxycycline 200 mg followed by 1 week placebo matching doxycycli
Sponsors
Liverpool School of Tropical Medicine (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 08/11/2012 (protocol change approved by the DMEC of this trial on 02/03/2011): 1. Men aged between 18 - 50 years 2. Good general health without any clinical condition requiring long-term medication and with normal renal and hepatic laboratory profiles 3. Body weight (BW): =40kg 4. Presence of at least one scrotal worm nest detected by ultrasonography Previous inclusion criteria until 08/11/2012: 3. Body weight (BW): 40 - 70 kg
Exclusion criteria
Exclusion criteria: 1. Known intolerance to the study drugs (doxycycline, rifampicin), or to ivermectin and/or albendazole 2. History of severe allergic reaction or anaphylaxis 3. History of alcohol or drug abuse 4. Anti-filarial therapy within the last 10 months 5. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, metabolic, rheumatologic or renal disease as far as it can be assessed by history of participants, physical examination, and/or laboratory examinations including blood and urine analysis 6. Laboratory evidence of liver disease (alanine aminotransferase [ALT], gamma-glutamyl transferase [gamma-GT] greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche®) 7. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal results as stated by the manufacturer of dipstick tests, Roche®) 8. Laboratory evidence of diabetes (urine dipstick chemistry) 9. Behavioural, cognitive or psychiatric disease that in the opinion of the trial clinician affects the ability of the participant to understand and comply with the study 10. Severe asthma or respiratory disease (emergency room visit or hospitalisation) 11. Undergone splenectomy 12. Participation in other drug trials concurrent with this study 13. Any other condition that, in the opinion of the investigator (trial clinician), would risk the safety or rights of a participant in the trial or would render the subject unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 08/11/2012 (protocol change approved by the DMEC of this trial on 02/03/2011, before de-blinding on 24/05/2011): Macrofilaricidal effect of the different treatment arms verified as absence of worm nests (Filaria Dance sign [FDS]; adult filariae in dilated lymphatic vessels) in the supratesticular vessels detected by ultrasonography, assessed 12 months after the start of drug administration. Previous primary outcome measures until 08/11/2012: Macrofilaricidal effect of the different treatment arms assessed by reduction in the number of worm nests (Filaria Dance sign [FDS]; adult filariae in dilated lymphatic vessels) in the supratesticular vessels detected by ultrasonography, measured pre-treatment as well as 12 months after the start of drug administration. For all above mentioned primary and secondary outcome measures: Treatment regimens 2 to 6 will subsequently be tested first for superiority compared to placebo (regimen 7) and second for equivalence to the standard therapy (regimen 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/11/2012 (protocol change approved by the DMEC of this trial on 02/03/2011, before de-blinding on 24/05/2011): 1. Macrofilaricidal effect of the different treatment arms verified as absence of FDS in the supratesticular vessels detected by ultrasonography, assessed 18 and 24 months after the start of drug administration 2. Macrofilaricidal effect of the different treatment arms assessed by reduction in the number of FDS in the supratesticular vessels detected by ultrasonography compared to pre-treatment, determined 12, 18 and 24 months after the start of drug administration 3. Macrofilaricidal effect of the different treatment arms assessed by reduction of circulating filarial antigen (CFA) levels compared to pre-treatment, measured by TropBio® ELISA and ICT card test 12, 18 and 24 months after the start of drug administration 4. Long-term sterilising effect of the female adult worms in the different treatment arms as assessed by microfilaria (mf) count (filtration method): 4.1 Reduction (%) or absence of microfilariae 4.2 Duration (months) of amicrofilaraemia 5. Reduction (%) or absence of Wolbachia ftsZ copy numbers/microfilariae compared to pre-treatment, assessed by polymerase chain reaction (PCR) 4, 12, 18 and 24 months after the start of drug administration 6. Reduction of supratesticular lymphatic vessel dilation compared to pre-treatment, measured 12, 18 and 24 months after the start of drug administration 7. Parasite specific immuno-globulin subclasses and cytokine responses, as well as other biomarkers such as vascular endothelial growth factors (VEGFs) measured pre-treatment as well as 4, 12 and 24 months after the start of drug administration Previous secondary outcome measures as of 01/12/2009, until 08/11/2012: 1. Macrofilaricidal effect of the different treatment arms assessed by reduction in the number of worm nests in the supratesticular vessels detected by ultrasonography, measured 18 and 24 months | — |
Countries
Ghana
Outcome results
None listed