Lymphatic filariasis (Wuchereria bancrofti) Infections and Infestations Filariasis
Conditions
Interventions
The participants will be randomised and assigned to one of two treatment regimens:
1. 6 weeks doxycycline (2 x 100 mg/day) (n = 33)
2. 6 weeks placebo matching doxycycline (2 capsules/day) (n = 33)
Sponsors
Volkswagen Foundation (VolkswagenStiftung) (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men between 18-55 years old 2. Good general health, without any clinical condition requiring long-term medication and with normal renal and hepatic laboratory profiles 3. Body weight > 40 kg 4. Presence of hydrocele stage 2 or 3, detected by ultrasound (as described in Debrah et al., 2007) 5. Willingness to participate in the study as evidenced by signing of the informed consent document (written or thumb print) 6. Resident in the endemic area for 5 years or more
Exclusion criteria
Exclusion criteria: 1. Known intolerance to the study drug doxycycline 2. History of a severe allergic reaction or anaphylaxis 3. History of alcohol or drug abuse 4. Evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatologic, metabolic or renal disease as far as it can be assessed by history of participants, physical examination, and/or laboratory examinations including blood and urine analyses 5. Laboratory evidence of liver disease (alanine aminotransferase [ALT], gamma-glutamyl transferase [gamma-GT] greater than 1.25 times the upper limit of normal results given by the dipstick test manufacturer, Roche?) 6. Laboratory evidence of renal disease (serum creatinine greater than 1.25 times the upper limit of normal results given by the dipstick test manufacturer, Roche?) 7. Laboratory evidence of diabetes (urine dipstick chemistry) 8.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 9. Severe asthma or respiratory disease (evidenced by a past emergency room visit or hospitalization) 10. Participation in other drug trials concurrent with this study 11. 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 |
|---|---|
| Improvement of filaricele size (stage) between study onset (pre-treatment) and 8 months after aspiration (12 months after study onset). Improvement is defined as pre-treatment stage of hydrocele minus one stage (minimum) 8 months after aspiration. Hydrocele stage is determined according to Debrah et al.,2007. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement of filaricele size (stage) between study onset (pre-treatment) and pre-aspiration (time point 4 months after doxycycline/placebo treatment) as well as 3 months after aspiration (7 months after study onset) 2. Improvement of filaricele size (stage) between pre-aspiration (4 months after study onset) and 3 and 8 months after aspiration (7 and 12 months after study onset) 3. Curative effect of the combined drug and aspiration treatment, measured at 3 and 8 months after aspiration (i.e. 7 and 12 months after drug treatment onset). A curative effect is defined as no fluid accumulation (no relapse after aspiration) 4. Reduction of supra-testicular lymphatic vessel dilation between pre-treatment and pre-aspiration as well as 3 and 8 months after aspiration (7 and 12 months after start of treatment) 5. Proof or rejection that improvement of hydrocele stage correlates with increase of immunosuppressive markers e.g. TGF, IL-10, lower levels of inflammatory cytokines e.g. IL-4, IL-6, IL-12, IL-17, INF?, TNF and decrease of angiogenic parameters, e.g. VEGFs, measured in blood samples pre-treatment, pre-aspiration as well as 3 and 8 months after aspiration (7 and 12 months after start of treatment) 6. Proof or rejection that improvement of hydrocele stage correlates with increase of immunosuppressive markers e.g. TGF, IL-10, lower levels of inflammatory cytokines e.g. IL-4, IL-6, IL-12, IL-17, INF?, TNF and decrease of angiogenic parameters, e.g. VEGFs, measured in hydrocele fluid obtained during aspiration. Clinical findings at 3 and 8 months after aspiration will be assessed and correlated with results of the aspirated fluid 7. Proof or rejection that USG is able to differentiate chylocele (EDH) from hydrocele (EFH) based on correlation of biochemical markers such as chylomicrons, lipoproteins, cytokines, with ultrasonographical findings | — |
Countries
Ghana
Outcome results
None listed