TrachomaPhase 3NCT03676140
Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs )
A Phase 3 study testing Albendazole on Day 1, Ivermectin on Day 1 and Diethylcarbamazine on day 1 in people with Trachoma and Yaws, run by Lihir Medical Centre at 1 site in Papua New Guinea.
Trial summary
This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF. Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trachoma, Yaws, Lymphatic Filariases
- What is being tested?
- Albendazole on Day 1, Ivermectin on Day 1 and Diethylcarbamazine on day 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- 1 Oct 2018to 1 Jan 2019
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able to give consent
Who cannot join
- Unable to give consent.
- Less than 5 years of age (not eligible for ivermectin)**
- Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)
- Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)**
- History of allergies to the drugs being studied
- Residents who cannot swallow tablets
- Note that patients that are not eligible for a specific drug will receive all other treatments and will be followed up through the same procedure as the other participants drug therapy to try to track any AEs attributed to specific drug combinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomised Trial of the Safety of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF.
Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately.
Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.
Read the detailed description
Recent studies have shown that single-dose combination therapy with three antifilarial drugs (Ivermectin [IVE] + DEC + ALB) called IDA is superior to current regimens used in LF elimination and may help accelerate LF elimination. WHO guidelines have changed to recommend IDA in countries endemic for LF outside sub-Saharan Africa like Papua New Guinea.
Additional benefits of IVE are its activity against scabies and Strongyloides. Treatment with IVE has shown to reduce the high prevalence of scabies in a village and in randomized control trials elsewhere in the Pacific. Of particular importance was the finding that IVE was highly effective against Strongyloides with a >95% reduction in prevalence sustained for nine months.
Increasingly, the desirability of linking LF programs with other public health initiatives also based on MDA is being appreciated. The existing programmatic infrastructure developed for LF campaign presents an attractive vehicle for a demonstration project of integration of MDAs against multiple Neglected Tropical Diseases (NTDs). The macrolide antibiotic azithromycin (AZI) has been demonstrated to be highly effective as MDA for yaws control and AZI is a highly effective and well-tolerated antibiotic treatment for trachoma that is able to clear ocular infection with a single oral dose and is well tolerated.
Currently LF/STH/Scabies/strongyloides and yaws/trachoma are treated separately. Integration of these existing MDA programs has the potential to be highly cost-effective as a population health intervention. Integration includes both the safe co-administration of medicines and operational planning, and it is currently advocated by WHO.
- Conditions
- Trachoma, Yaws, Lymphatic Filariases, Scabies, Strongyloidiasis
- Being tested
- Albendazole on Day 1, Ivermectin on Day 1, Diethylcarbamazine on day 1, Azithromycin on Day 1, Azithromycin on Day 8
- Keywords
- Neglected Tropical Diseases
- Medical subject headings
- Trachoma, Yaws, Elephantiasis, Filarial, Scabies, Strongyloidiasis, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole on Day 1Drug
Also called Albenza
Albendazole 400 mg oral tablet Single Dose Treatment on D1
Ivermectin on Day 1Drug
Also called Mectizan
Ivermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1
Diethylcarbamazine on day 1Drug
Also called DEC-d1, Banocide
Diethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1
Azithromycin on Day 1Drug
Also called Zithromax
Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 1
Azithromycin on Day 8Drug
Also called Zithromax
Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8
| Study group | Role | What they receive |
|---|---|---|
| Separate Administration | Active comparator | 'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8' Receives: Drug: Albendazole on Day 1; Drug: Ivermectin on Day 1; Drug: Diethylcarbamazine on day 1; Drug: Azithromycin on Day 8 |
| Co-Administration | Experimental | 'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1' Receives: Drug: Albendazole on Day 1; Drug: Ivermectin on Day 1; Drug: Diethylcarbamazine on day 1; Drug: Azithromycin on Day 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported Adverse Event
The incidence of self-reported adverse events following MDA. We will collect data on the presence of common symptoms/signs prior to drug administration. All patients will be reviewed 24-48 hours after treatment and asked to report adverse events. We will calculate the proportion of newly occurring adverse events following treatment and calculate the whether the proportion of patients experiencing an adverse event differs between study arms.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Oct 2018
- Primary completion15 Dec 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrachomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lihir Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Oriol Mitja, Lihir Medical Centre
- Investigators
- Lucy John, MD, Principal investigator, National Department of Health of Papua New Guinea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676140
- Sponsor's protocol ID
- ComboNTDs - CRT
- Status last verified
- Feb 2019
- First submitted
- 16 Sep 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Cluster Randomised Trial of the Safety of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases
- ClinicalTrials.gov ID
- NCT03676140
- Acronym / sponsor ID
- ComboNTDs - CRT
- Conditions
- Trachoma, Yaws, Lymphatic Filariases, Scabies, Strongyloidiasis
- Keywords
- Neglected Tropical Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- Lihir Medical CentreUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 18 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 cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF.
Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately.
Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.
Detailed description
Recent studies have shown that single-dose combination therapy with three antifilarial drugs (Ivermectin [IVE] + DEC + ALB) called IDA is superior to current regimens used in LF elimination and may help accelerate LF elimination. WHO guidelines have changed to recommend IDA in countries endemic for LF outside sub-Saharan Africa like Papua New Guinea.
Additional benefits of IVE are its activity against scabies and Strongyloides. Treatment with IVE has shown to reduce the high prevalence of scabies in a village and in randomized control trials elsewhere in the Pacific. Of particular importance was the finding that IVE was highly effective against Strongyloides with a >95% reduction in prevalence sustained for nine months.
Increasingly, the desirability of linking LF programs with other public health initiatives also based on MDA is being appreciated. The existing programmatic infrastructure developed for LF campaign presents an attractive vehicle for a demonstration project of integration of MDAs against multiple Neglected Tropical Diseases (NTDs). The macrolide antibiotic azithromycin (AZI) has been demonstrated to be highly effective as MDA for yaws control and AZI is a highly effective and well-tolerated antibiotic treatment for trachoma that is able to clear ocular infection with a single oral dose and is well tolerated.
Currently LF/STH/Scabies/strongyloides and yaws/trachoma are treated separately. Integration of these existing MDA programs has the potential to be highly cost-effective as a population health intervention. Integration includes both the safe co-administration of medicines and operational planning, and it is currently advocated by WHO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Separate Administration | Active comparator | Drug: Albendazole on Day 1, Drug: Ivermectin on Day 1, Drug: Diethylcarbamazine on day 1, Drug: Azithromycin on Day 8'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8' |
| Co-Administration | Experimental | Drug: Albendazole on Day 1, Drug: Ivermectin on Day 1, Drug: Diethylcarbamazine on day 1, Drug: Azithromycin on Day 1'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1' |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Able to give consent
Key exclusion criteria (7 listed)
- Unable to give consent.
- Less than 5 years of age (not eligible for ivermectin)**
- Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)
- Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)**
- History of allergies to the drugs being studied
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 |
|---|---|---|
| Albendazole on Day 1Also: AlbenzaAlbendazole 400 mg oral tablet Single Dose Treatment on D1 | Drug | Co-Administration, Separate Administration |
| Ivermectin on Day 1Also: MectizanIvermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1 | Drug | Co-Administration, Separate Administration |
| Diethylcarbamazine on day 1Also: DEC-d1, BanocideDiethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1 | Drug | Co-Administration, Separate Administration |
| Azithromycin on Day 1Also: ZithromaxAzithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 1 | Drug | Co-Administration |
| Azithromycin on Day 8Also: ZithromaxAzithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8 | Drug | Separate Administration |
Primary outcome
Self Reported Adverse Event
Time frame: 7 Days
The incidence of self-reported adverse events following MDA. We will collect data on the presence of common symptoms/signs prior to drug administration. All patients will be reviewed 24-48 hours after treatment and asked to report adverse events. We will calculate the proportion of newly occurring adverse events following treatment and calculate the whether the proportion of patients experiencing an adverse event differs between study arms.
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.
- Individual participant dataSharing planned: No
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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.
Lucy John, MD principal investigator
National Department of Health of Papua New Guinea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albendazole on Day 1, Ivermectin on Day 1 and Diethylcarbamazine on day 1 in people with Trachoma 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 1 inclusion and 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Self Reported Adverse Event (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.