CompletedPhase 2

PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

Papua New Guinea42 participantsStarted 2018-09-01

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult aged 18-65 * Able to give informed consent Exclusion Criteria: * Known chronic illness * Hb \<7 at baseline * Liver function or Creatinine \* 1.5 Upper Limit of Normal * Urinary tract infection at baseline * Pregnancy (female participants only) * Routine medications which interact with study drugs * Lactose/Gluten intolerance * Permanent disability impeding study participation

What they're measuring

Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole

Timeframe: 4 Days

Trial details

NCT IDNCT03664063

SponsorLihir Medical Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-01

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