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

Lihir Medical Centre

Status and phase: Completed; Phase 2

Conditions: Yaws; Lymphatic Filariasis; Trauma

Treatments: Drug: Ivermectin; Drug: Diethylcarbamazine; Drug: Azithromycin; Drug: Albendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT03664063

ComboNTDs-PK

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 3 patient groups

Azithromycin for Yaws

Active Comparator group

Description:

Patients will receive standard treatment for yaws alone

Treatment:

Drug: Azithromycin

IDA for Lymphatic Filariasis

Active Comparator group

Description:

Patients will receive standard IDA (Ivermectin \& Diethylcarbamazine \& Albendazole) treatment for Lymphatic Filariasis alone

Treatment:

Drug: Albendazole

Drug: Diethylcarbamazine

Drug: Ivermectin

Combination Therapy of Azithromycin for Yaws and IDA for LF

Experimental group

Description:

Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.

Treatment:

Drug: Albendazole

Drug: Azithromycin

Drug: Diethylcarbamazine

Drug: Ivermectin