Lymphatic FilariasisPhase 2NCT03664063
PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )
A Phase 2 study testing Azithromycin, Albendazole and Ivermectin in people with Lymphatic Filariasis and Yaws, run by Lihir Medical Centre at 1 site in Papua New Guinea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Filariasis, Yaws, Trauma
- What is being tested?
- Azithromycin, Albendazole and Ivermectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- 1 Sep 2018to 1 Jan 2019
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult aged 18-65
- Able to give informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Papua New Guinea1 site
Lihir Medical Centre
Londolovit, New Ireland Province, 034
About this study
Official title: A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
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
- Being tested
- Azithromycin, Albendazole, Ivermectin, Diethylcarbamazine
- Medical subject headings
- Elephantiasis, Filarial, Yaws, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Treatment with Azithromycin single dose - weight based dosing max 2gm
AlbendazoleDrug
Also called IDA
Single dose of Albendazole weight based dosing
- 400mg
IvermectinDrug
Also called IDA
Ivermectin weight based dosing - max 21mg
DiethylcarbamazineDrug
Also called IDA
Diethylcarbamazine weight based dosing - max 500mg
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin for Yaws | Active comparator | Patients will receive standard treatment for yaws alone Receives: Drug: Azithromycin |
| IDA for Lymphatic Filariasis | Active comparator | Patients will receive standard IDA (Ivermectin \& Diethylcarbamazine \& Albendazole) treatment for Lymphatic Filariasis alone Receives: 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. Receives: Drug: Azithromycin; Drug: Albendazole; Drug: Ivermectin; Drug: Diethylcarbamazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole
Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole
Measured: 4 Days
Secondary outcomes (1)
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
Measured: Four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Sep 2018
- Primary completion1 Oct 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphatic FilariasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lihir Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oriol Mitja, Lihir Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664063
- Sponsor's protocol ID
- ComboNTDs-PK
- Status last verified
- Feb 2019
- First submitted
- 3 Sep 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alshehri A, King CL, Murry DJ. Population pharmacokinetics modeling of albendazole and its active metabolite, albendazole sulfoxide in mass drug administration against lymphatic filariasis. Antimicrob Agents Chemother. 2026 Oct 8:e0056226. doi: 10.1128/aac.00562-26. Online ahead of print.
PubMed 42848323Alshehri 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.
PubMed 37262040John 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.
PubMed 32818264