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

Study Overview
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Brief Summary
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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.

Official Title
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A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases

Conditions
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Yaws, Lymphatic Filariasis, Trauma

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Albendazole
* Drug: Ivermectin
* Drug: Diethylcarbamazine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azithromycin for Yaws<br>Patients will receive standard treatment for yaws alone | Drug: Azithromycin<br>* Treatment with Azithromycin single dose - weight based dosing max 2gm<br>|
| Active Comparator: IDA for Lymphatic Filariasis<br>Patients will receive standard IDA (Ivermectin & Diethylcarbamazine & Albendazole) treatment for Lymphatic Filariasis alone | Drug: Albendazole<br>* Single dose of Albendazole weight based dosing - 400mg<br>* Other names: IDA;Drug: Ivermectin<br>* Ivermectin weight based dosing - max 21mg<br>* Other names: IDA;Drug: Diethylcarbamazine<br>* Diethylcarbamazine weight based dosing - max 500mg<br>* Other names: IDA;|
| Experimental: Combination Therapy of Azithromycin for Yaws and IDA for LF<br>Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time. | Drug: Azithromycin<br>* Treatment with Azithromycin single dose - weight based dosing max 2gm<br>Drug: Albendazole<br>* Single dose of Albendazole weight based dosing - 400mg<br>* Other names: IDA;Drug: Ivermectin<br>* Ivermectin weight based dosing - max 21mg<br>* Other names: IDA;Drug: Diethylcarbamazine<br>* Diethylcarbamazine weight based dosing - max 500mg<br>* Other names: IDA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole | Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole | 4 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Four days |