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

NCT03664063 | Completed Phase 2

• 1 other identifier: ComboNTDs-PK
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphatic Filariasis; Yaws; Trauma

Outcome Measures

Primary Outcomes (1)

• Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole

  Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole

  4 Days

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Four days

Study Arms (3)

Azithromycin for Yaws

ACTIVE COMPARATOR

Patients will receive standard treatment for yaws alone

Drug: Azithromycin

IDA for Lymphatic Filariasis

ACTIVE COMPARATOR

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

Drug: Albendazole; Drug: Ivermectin; Drug: Diethylcarbamazine

Combination Therapy of Azithromycin for Yaws and IDA for LF

EXPERIMENTAL

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

Interventions

Azithromycin DRUG

Treatment with Azithromycin single dose - weight based dosing max 2gm

Azithromycin for Yaws; Combination Therapy of Azithromycin for Yaws and IDA for LF

Albendazole DRUG

Single dose of Albendazole weight based dosing \- 400mg

Also known as: IDA

Combination Therapy of Azithromycin for Yaws and IDA for LF; IDA for Lymphatic Filariasis

Ivermectin DRUG

Ivermectin weight based dosing - max 21mg

Also known as: IDA

Combination Therapy of Azithromycin for Yaws and IDA for LF; IDA for Lymphatic Filariasis

Diethylcarbamazine DRUG

Diethylcarbamazine weight based dosing - max 500mg

Also known as: IDA

Combination Therapy of Azithromycin for Yaws and IDA for LF; IDA for Lymphatic Filariasis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged 18-65
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Lihir Medical Centre: lead

Study Sites (1)

Lihir Medical Centre

Londolovit, New Ireland Province, 034, Papua New Guinea

Location

Related Publications (2)

• Alshehri A, Chhonker YS, Bala V, Edi C, Bjerum CM, Koudou BG, John LN, Mitja O, Marks M, King CL, Murry DJ. Population pharmacokinetic model of ivermectin in mass drug administration against lymphatic filariasis. PLoS Negl Trop Dis. 2023 Jun 1;17(6):e0011319. doi: 10.1371/journal.pntd.0011319. eCollection 2023 Jun.

  PMID: 37262040 DERIVED

• John LN, Bjerum C, Martinez PM, Likia R, Silus L, Wali C, Elizah A, Chhonker YS, Bala V, King CL, Murry DJ, Mitja O, Marks M. Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases. Clin Infect Dis. 2020 Aug 20:ciaa1202. doi: 10.1093/cid/ciaa1202. Online ahead of print.

  PMID: 32818264 DERIVED

MeSH Terms

Conditions

Elephantiasis, Filarial; Yaws; Wounds and Injuries

Interventions

Azithromycin; Albendazole; Ivermectin; Diethylcarbamazine

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 10, 2018
• Study Start: September 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 28, 2019

Record last verified: 2019-02

Locations

PA (1)