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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic and Pharmacodynamic Evaluation of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
- ClinicalTrials.gov ID
- NCT03664063
- Acronym / sponsor ID
- ComboNTDs-PK
- Conditions
- Lymphatic Filariasis, Yaws, Trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Lihir Medical CentreUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Azithromycin for Yaws | Active comparator | Drug: AzithromycinPatients will receive standard treatment for yaws alone |
| IDA for Lymphatic Filariasis | Active comparator | Drug: Albendazole, Drug: Ivermectin, Drug: DiethylcarbamazinePatients will receive standard IDA (Ivermectin \& Diethylcarbamazine \& Albendazole) treatment for Lymphatic Filariasis alone |
| Combination Therapy of Azithromycin for Yaws and IDA for LF | Experimental | Drug: Azithromycin, Drug: Albendazole, Drug: Ivermectin, Drug: DiethylcarbamazinePatients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult aged 18-65
- Able to give informed consent
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinTreatment with Azithromycin single dose - weight based dosing max 2gm | Drug | Azithromycin for Yaws, Combination Therapy of Azithromycin for Yaws and IDA for LF |
| AlbendazoleAlso: IDASingle dose of Albendazole weight based dosing - 400mg | Drug | Combination Therapy of Azithromycin for Yaws and IDA for LF, IDA for Lymphatic Filariasis |
| IvermectinAlso: IDAIvermectin weight based dosing - max 21mg | Drug | Combination Therapy of Azithromycin for Yaws and IDA for LF, IDA for Lymphatic Filariasis |
| DiethylcarbamazineAlso: IDADiethylcarbamazine weight based dosing - max 500mg | Drug | Combination Therapy of Azithromycin for Yaws and IDA for LF, IDA for Lymphatic Filariasis |
Primary outcome
Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole
Time frame: 4 Days
Plasma concentrations of Azithromycin, Ivermectin, Diethylcarbamize, Albendazole
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Four days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Derived from this study: PubMed 42848323Alshehri 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.
- Derived from this study: PubMed 37262040Alshehri 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.
- Derived from this study: PubMed 32818264John 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.
Related trials for Lymphatic Filariasis
Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
RecruitingPhase 3
Better Options for Lymphatic Filariasis Treatment
Lymphatic Filariasis, Scabies
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Papua New Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug levels of Azithromycin, Ivermectin, Diethylcarbamazine, Albendazole (time frame: 4 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03664063, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.