A Phase 2 interventional study of Azithromycin and Albendazole in Lymphatic Filariasis, Yaws and Trauma, sponsored by Lihir Medical Centre. Completed at 1 site in Papua New Guinea. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by Lihir Medical Centre · Phase 2, Interventional, and Treatment
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.
42 studies on the registry are indexed under Elephantiasis, Filarial; 5 are open to participants now.
This study's enrollment of 42 is below the median of 1,000 across 27 interventional studies indexed under Elephantiasis, Filarial.
Browse Elephantiasis, Filarial studies →Lihir Medical Centre is the lead sponsor of 7 studies on the registry; none are open to participants now.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive standard treatment for yaws alone
Drug: Azithromycin
Patients will receive standard IDA (Ivermectin \& Diethylcarbamazine \& Albendazole) treatment for Lymphatic Filariasis alone
Drug: Albendazole · Drug: Ivermectin · Drug: Diethylcarbamazine
Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
Drug: Azithromycin · Drug: Albendazole · Drug: Ivermectin · Drug: Diethylcarbamazine
Treatment with Azithromycin single dose - weight based dosing max 2gm
Single dose of Albendazole weight based dosing - 400mg
Also known as: IDA
Ivermectin weight based dosing - max 21mg
Also known as: IDA
Diethylcarbamazine weight based dosing - max 500mg
Also known as: IDA
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
Ran from Sep 2018 to primary completion in Oct 2018, 1 month.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Azithromycin · Albendazole · Ivermectin · Diethylcarbamazine
Lihir Medical Centre