This is a Pharmacokinetic and Pharmacodynamic study evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Individuals will be randomised to receive Azithromycin alone, IDA or combination therapy. Clinical and biochemical monitoring for safety will be undertaken. Drug levels will be measured in each of the three arms to assess whether combination therapy significantly alters drug levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Treatment with Azithromycin single dose - weight based dosing max 2gm
Single dose of Albendazole weight based dosing \- 400mg
Ivermectin weight based dosing - max 21mg
Lihir Medical Centre
Londolovit, New Ireland Province, Papua New Guinea
Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole
Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole
Time frame: 4 Days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Patients will undergo regular monitoring for the duration of the study - adverse events will be graded from 1 to 4 in line with the CTCAE v4.0
Time frame: Four days
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Diethylcarbamazine weight based dosing - max 500mg