A Phase 3 interventional study of Albendazole on Day 1 and Ivermectin on Day 1 in Trachoma, Yaws and Lymphatic Filariases, sponsored by Lihir Medical Centre. Completed at 1 site in Papua New Guinea. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by Lihir Medical Centre · Phase 3, Interventional, and Treatment
This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF.
Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately.
Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.
Recent studies have shown that single-dose combination therapy with three antifilarial drugs (Ivermectin [IVE] + DEC + ALB) called IDA is superior to current regimens used in LF elimination and may help accelerate LF elimination. WHO guidelines have changed to recommend IDA in countries endemic for LF outside sub-Saharan Africa like Papua New Guinea.
Additional benefits of IVE are its activity against scabies and Strongyloides. Treatment with IVE has shown to reduce the high prevalence of scabies in a village and in randomized control trials elsewhere in the Pacific. Of particular importance was the finding that IVE was highly effective against Strongyloides with a >95% reduction in prevalence sustained for nine months.
Increasingly, the desirability of linking LF programs with other public health initiatives also based on MDA is being appreciated. The existing programmatic infrastructure developed for LF campaign presents an attractive vehicle for a demonstration project of integration of MDAs against multiple Neglected Tropical Diseases (NTDs). The macrolide antibiotic azithromycin (AZI) has been demonstrated to be highly effective as MDA for yaws control and AZI is a highly effective and well-tolerated antibiotic treatment for trachoma that is able to clear ocular infection with a single oral dose and is well tolerated.
Currently LF/STH/Scabies/strongyloides and yaws/trachoma are treated separately. Integration of these existing MDA programs has the potential to be highly cost-effective as a population health intervention. Integration includes both the safe co-administration of medicines and operational planning, and it is currently advocated by WHO.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 20,000 is above the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →Lihir Medical Centre is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note that patients that are not eligible for a specific drug will receive all other treatments and will be followed up through the same procedure as the other participants drug therapy to try to track any AEs attributed to specific drug combinations
'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'
Drug: Albendazole on Day 1 · Drug: Ivermectin on Day 1 · Drug: Diethylcarbamazine on day 1 · Drug: Azithromycin on Day 8
'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1'
Drug: Albendazole on Day 1 · Drug: Ivermectin on Day 1 · Drug: Diethylcarbamazine on day 1 · Drug: Azithromycin on Day 1
Albendazole 400 mg oral tablet Single Dose Treatment on D1
Also known as: Albenza
Ivermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1
Also known as: Mectizan
Diethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1
Also known as: DEC-d1, Banocide
Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 1
Also known as: Zithromax
Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8
Also known as: Zithromax
Self Reported Adverse Event
The incidence of self-reported adverse events following MDA. We will collect data on the presence of common symptoms/signs prior to drug administration. All patients will be reviewed 24-48 hours after treatment and asked to report adverse events. We will calculate the proportion of newly occurring adverse events following treatment and calculate the whether the proportion of patients experiencing an adverse event differs between study arms.
Time frame: 7 Days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Azithromycin
Lihir Medical Centre