TrachomaPhase 4NCT03570814
Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin
A Phase 4 study testing Administration of Albendazole on Day 1, Administration of Ivermectin on Day 1 and Administration of Azithromycin on Day 1 in people with Trachoma and Lymphatic Filariases, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
Trial summary
Cluster-randomised trial comparing co-administration of Azithromycin/Ivermectin/Albendazole with separate administration of Azithromycin and Ivermectin/Albendazole. The study will be conducted in Beneshangul-Gumuz region, Ethiopia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trachoma, Lymphatic Filariases
- What is being tested?
- Administration of Albendazole on Day 1, Administration of Ivermectin on Day 1 and Administration of Azithromycin on Day 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,511 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Dec 2021to 1 Feb 2022
- Phase
- Phase 4
- 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
- Residing in the community for at least three months;
- Eligible to receive all three agents according to standard MDA criteria
Who cannot join
- Not eligible to receive one or more drugs according to standard MDA criteria;
- 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 (azithromycin, ivermectin, albendazole)
- Residents who cannot swallow tablets
- Note that patients that are not eligible for IVM, will receive azithromycin and albendazole. Patients that receive azithromycin and albendazole will be followed up through the same procedure as the triple drug therapy to try to track any AEs attributed to the two drug combination.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Community Recruitment across whole district
Community Recruitment Across Whole District
About this study
Official title: Safety of the Co-administration of Azithromycin, Albendazole and Ivermectin Versus Standard Treatment Regimens During Mass Drug Administration (MDA) in Ethiopia: a Cluster-randomized Trial
Cluster-randomised trial comparing co-administration of Azithromycin/Ivermectin/Albendazole with separate administration of Azithromycin and Ivermectin/Albendazole.
The study will be conducted in Beneshangul-Gumuz region, Ethiopia. Within this district, a study group of 8,000 people (in approximately 40 clusters) will receive the azithromycin, ivermectin \& albendazole at a single time. A control group of 8,000 people (in approximately 40 clusters) within the same district will receive the current MDA treatment schedule beginning with Ivermectin/Albendazole followed two weeks later with azithromycin. All drug dosing will be in line with standard FMOH and WHO Guidelines for MDA for trachoma and lymphatic filariasis.
The study will randomly sort subdistrict communities (Gotes) into the trial arm and the control arm. The study will compare the number of adverse events (AEs) and severe adverse events (SAEs) between the two arms to determine if co-administration is not inferior to the standard treatment. The primary outcome will be to demonstrate the safety of the triple-drug administration as measured by incidence of AEs/SAEs following the MDA.
- Conditions
- Trachoma, Lymphatic Filariases
- Being tested
- Administration of Albendazole on Day 1, Administration of Ivermectin on Day 1, Administration of Azithromycin on Day 1, Administration of Azithromycin on Day 15
- Medical subject headings
- Trachoma, Elephantiasis, Filarial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Albendazole on Day 1Drug
Participants will receive Albendazole 400mg on study day 1.
Administration of Ivermectin on Day 1Drug
Participants will receive Ivermectin 150mcg/kg (max 12mg) on study day 1. Doses of Ivermectin will be determined using a standard dosing pole.
Administration of Azithromycin on Day 1Drug
Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 1. Doses of Azithromycin will be determined using a standard dosing pole.
Administration of Azithromycin on Day 15Drug
Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 15. Doses of Azithromycin will be determined using a standard dosing pole.
| Study group | Role | What they receive |
|---|---|---|
| Separate Administration | Active comparator | Standard administration of Albendazole/Ivermectin separated from administration of azithromycin Receives: Drug: Administration of Albendazole on Day 1; Drug: Administration of Ivermectin on Day 1; Drug: Administration of Azithromycin on Day 15 |
| Co-administration | Experimental | Combined administration of Albendazole/Ivermectin/Azithromycin at a single time point Receives: Drug: Administration of Albendazole on Day 1; Drug: Administration of Ivermectin on Day 1; Drug: Administration of 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: 1 Month
Secondary outcomes (2)
Cost of Administration Drug Separately compared to Cost of Co-Administration of Drugs
Analysis of the cost effectiveness of co-administration compared to separate administration of drugs
Measured: 1 month
Community perceptions
An analysis of community perceptions of benefits of co-administration at a single time point vs standard separated MDA will be conducted by conducting focus groups and in-depth interviews with study participants.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Dec 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised trial. Approximately 40 clusters per study arm
- Masking
- None (open label)
- Enrolment
- 13,511 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia, Federal Minstry of Health of Ethiopia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570814
- Sponsor's protocol ID
- 11985
- Status last verified
- Apr 2022
- First submitted
- 4 Jun 2018
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McPherson S, Tafese G, Tafese T, Behaksra SW, Solomon H, Oljira B, Miecha H, Debebe KA, Kebede B, Gebre T, Kebede F, Seife F, Tadesse F, Mammo B, Aseffa A, Solomon AW, Mabey DCW, Marks M, Gadisa E. Safety of integrated mass drug administration of azithromycin, albendazole and ivermectin versus standard treatment regimens: a cluster-randomised trial in Ethiopia. EClinicalMedicine. 2023 Apr 27;59:101984. doi: 10.1016/j.eclinm.2023.101984. eCollection 2023 May.
PubMed 37152362
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the Co-administration of Azithromycin, Albendazole and Ivermectin Versus Standard Treatment Regimens During Mass Drug Administration (MDA) in Ethiopia: a Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT03570814
- Acronym / sponsor ID
- 11985
- Conditions
- Trachoma, Lymphatic Filariases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,511 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia, Federal Minstry of Health of Ethiopia
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 27 Jun 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.
Cluster-randomised trial comparing co-administration of Azithromycin/Ivermectin/Albendazole with separate administration of Azithromycin and Ivermectin/Albendazole.
The study will be conducted in Beneshangul-Gumuz region, Ethiopia. Within this district, a study group of 8,000 people (in approximately 40 clusters) will receive the azithromycin, ivermectin \& albendazole at a single time. A control group of 8,000 people (in approximately 40 clusters) within the same district will receive the current MDA treatment schedule beginning with Ivermectin/Albendazole followed two weeks later with azithromycin. All drug dosing will be in line with standard FMOH and WHO Guidelines for MDA for trachoma and lymphatic filariasis.
The study will randomly sort subdistrict communities (Gotes) into the trial arm and the control arm. The study will compare the number of adverse events (AEs) and severe adverse events (SAEs) between the two arms to determine if co-administration is not inferior to the standard treatment. The primary outcome will be to demonstrate the safety of the triple-drug administration as measured by incidence of AEs/SAEs following the MDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomised trial. Approximately 40 clusters per study arm
| Arm | Type | Receives |
|---|---|---|
| Separate Administration | Active comparator | Drug: Administration of Albendazole on Day 1, Drug: Administration of Ivermectin on Day 1, Drug: Administration of Azithromycin on Day 15Standard administration of Albendazole/Ivermectin separated from administration of azithromycin |
| Co-administration | Experimental | Drug: Administration of Albendazole on Day 1, Drug: Administration of Ivermectin on Day 1, Drug: Administration of Azithromycin on Day 1Combined administration of Albendazole/Ivermectin/Azithromycin at a single time point |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Residing in the community for at least three months;
- Eligible to receive all three agents according to standard MDA criteria
Key exclusion criteria (7 listed)
- Not eligible to receive one or more drugs according to standard MDA criteria;
- 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 (azithromycin, ivermectin, albendazole)
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 |
|---|---|---|
| Administration of Albendazole on Day 1Participants will receive Albendazole 400mg on study day 1. | Drug | Co-administration, Separate Administration |
| Administration of Ivermectin on Day 1Participants will receive Ivermectin 150mcg/kg (max 12mg) on study day 1. Doses of Ivermectin will be determined using a standard dosing pole. | Drug | Co-administration, Separate Administration |
| Administration of Azithromycin on Day 1Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 1. Doses of Azithromycin will be determined using a standard dosing pole. | Drug | Co-administration |
| Administration of Azithromycin on Day 15Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 15. Doses of Azithromycin will be determined using a standard dosing pole. | Drug | Separate Administration |
Primary outcome
Self Reported Adverse Event
Time frame: 1 Month
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,
2 secondary outcomes
Cost of Administration Drug Separately compared to Cost of Co-Administration of Drugs
Time frame: 1 month
Community perceptions
Time frame: 1 month
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 19 Aug 2022.
- Derived from this study: PubMed 37152362McPherson S, Tafese G, Tafese T, Behaksra SW, Solomon H, Oljira B, Miecha H, Debebe KA, Kebede B, Gebre T, Kebede F, Seife F, Tadesse F, Mammo B, Aseffa A, Solomon AW, Mabey DCW, Marks M, Gadisa E. Safety of integrated mass drug administration of azithromycin, albendazole and ivermectin versus standard treatment regimens: a cluster-randomised trial in Ethiopia. EClinicalMedicine. 2023 Apr 27;59:101984. doi: 10.1016/j.eclinm.2023.101984. eCollection 2023 May.
- Individual participant dataSharing planned: Undecided
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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.
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 4 study testing Administration of Albendazole on Day 1, Administration of Ivermectin on Day 1 and Administration of Azithromycin on Day 1 in people with Trachoma and Lymphatic Filariases, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
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 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 19 Aug 2022. 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 Ethiopia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: 1 Month). 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 NCT03570814, which also lists 1 linked publication.
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 19 Aug 2022.