TrachomaPhase 4AZIVAL2NCT01903057
Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis
A Phase 4 study testing azithromycin, ivermectin and albendazole in people with Trachoma and Lymphatic Filariasis, run by Emory University at 1 site in Mozambique.
Trial summary
Trachoma and lymphatic filariasis (LF) are two 'Neglected Tropical Diseases' (NTDs), infectious diseases that affect millions of poor people in countries in the developing world. Trachoma is an eye infection that can lead to painful scarring of the eyelids and blindness later in life. Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trachoma, Lymphatic Filariasis
- What is being tested?
- azithromycin, ivermectin and albendazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMozambique
- Study dates
- Feb 2014to Jul 2014
- 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 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 5 years and ≤ 65 years.
- Height ≥ 90 cm
- Able to understand the information and consent and assent forms, willing to give consent and assent, and abide by the study restrictions (parent or guardian consent if study participant age is < 18 years, participant to assent form if age < 18 years and ≥ 7 years)
- Residence in the study site for at least three months prior to enrolment
- Willing to remain in the study site for the duration of the study
- Willing and able to provide necessary samples to permit evaluation.
Who cannot join
- Unable to swallow tablets
- History of hypersensitivity/allergy to azithromycin, ivermectin, and/or albendazole
- Treatment with another investigational agent/intervention within 4 weeks prior to study entry
- Pregnancy (demonstrated by positive urine pregnancy test, performed by study staff, or evidently pregnant). All women of child bearing age (≥ 12 years and ≤ 49 years in Nampula province, personal communication, Arlinda Martins) will undergo a urine pregnancy test (unless they are evidently pregnant) to exclude pregnancy.
- Breast-feeding mother.
- Any condition that, in the opinion of the investigator, might interfere with the outcome of the study and/or adherence to the follow up schedule, such as clinically significant illness.
Trial locations and contacts
1 site in 1 country.
Mozambique1 site
National Institute of Health, Ministry of Health
Maputo, Cidade de Maputo
About this study
Official title: AZIVAL 2: A Double-blind Cluster-randomized Placebo-controlled Study on the Safety of Integrated Treatment of Trachoma and Lymphatic Filariasis in Children and Adults With Azithromycin, Ivermectin and Albendazole
Trachoma and lymphatic filariasis (LF) are two 'Neglected Tropical Diseases' (NTDs), infectious diseases that affect millions of poor people in countries in the developing world. Trachoma is an eye infection that can lead to painful scarring of the eyelids and blindness later in life. LF can lead to swelling of usually the limbs (elephantiasis).
Trachoma and LF are preventable and treatable diseases. One important treatment strategy is annual Mass Drug Administration (MDA): Communities receive drug treatment once a year. Azithromycin is given for trachoma. Ivermectin and albendazole are given for LF.
Read more
Trachoma MDA and LF MDA are currently separated campaigns. Combined MDA campaigns for trachoma and LF, where three drugs would be given at one time, would reduce costs and decrease the burden on the health system.
Before combined MDA with three drugs (azithromycin, ivermectin and albendazole) could be recommended, we would have to demonstrate that the safety profile of this treatment with three drugs is acceptable. An earlier study in Mali in 2010 (AZIVAL) comparing standard MDA (one week space between the two MDA campaigns) with combined MDA (trachoma and LF MDA on the same day) showed that the safety profiles were comparable; but the results of the study were not statistically significant and we could not use them to make an official recommendation.
The AZIVAL 2 study has been designed to answer the questions that remain after the AZIVAL study performed in Mali in 2010. If the safety results of the AZIVAL 2 study are acceptable, an official recommendation for combined MDA with azithromycin, ivermectin and albendazole can be drafted.
We will conduct the AZIVAL 2 study in Mozambique. The target population (inclusion and exclusion criteria) is the same as in the AZIVAL study in Mali. Main criteria are: Age ≥ 5 years and ≤ 65 years, height ≥ 90 cm, if female, not pregnant or breast-feeding.
Important differences between the AZIVAL study and the AZIVAL 2 study are a) smaller clusters for sufficient power (average household size is 5 people), b) placebo to double-blind participants and study staff for azithromycin, c) the study area will have undergone fewer previous rounds of MDA for LF and none for trachoma, and d) smartphones for data entry.
- Conditions
- Trachoma, Lymphatic Filariasis
- Being tested
- azithromycin, ivermectin, albendazole, placebo
- Keywords
- Mass Drug Administration, Neglected Tropical Diseases, Preventive Chemotherapy and Transmission Control, Preventive Chemotherapy
- Medical subject headings
- Trachoma, Elephantiasis, Filarial, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycinDrug
ivermectinDrug
albendazoleDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Combination treatment | Experimental | Combination treatment with azithromycin, ivermectin and albendazole on day 1, followed by placebo on day 8
Placebo has same appearance and dosing as azithromycin. Receives: Drug: azithromycin; Drug: ivermectin; Drug: albendazole; Drug: placebo |
| Control (Standard of Care) | Placebo comparator | Standard treatment with placebo, ivermectin and albendazole on day 1, followed by azithromycin on day 8
Placebo has same appearance and dosing as azithromycin. Receives: Drug: azithromycin; Drug: ivermectin; Drug: albendazole; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall rate of adverse events and serious adverse events in each group
Measured: 15 days
Secondary outcomes (5)
The types of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Measured: 15 days
The incidences of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Measured: 15 days
The timing of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Measured: 15 days
The duration of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Measured: 15 days
The intensities of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startFeb 2014
- Primary completionMar 2014 (estimated)
- Study completionJul 2014 (estimated)
Why it stopped: As of November 2013, the security situation in rural Northern Mozambique is no longer suitable for this clinical trial.
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.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huub Gelderblom MD, PhD, MPH, Emory University
- Investigators
- Huub C Gelderblom, MD, PhD, MPH, Principal investigator, Emory UniversityRicardo Thompson, PhD, Principal investigator, Instituto Nacional de Saude, Ministry of Health of Mozambique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903057
- Sponsor's protocol ID
- IRB00065751
- Other IDs
- ITI2012-001
- Acronym
- AZIVAL2
- Status last verified
- May 2014
- First submitted
- 15 Jul 2013
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coulibaly YI, Dicko I, Keita M, Keita MM, Doumbia M, Daou A, Haidara FC, Sankare MH, Horton J, Whately-Smith C, Sow SO. A cluster randomized study of the safety of integrated treatment of trachoma and lymphatic filariasis in children and adults in Sikasso, Mali. PLoS Negl Trop Dis. 2013 May 9;7(5):e2221. doi: 10.1371/journal.pntd.0002221. Print 2013.
PubMed 23675549
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AZIVAL 2: A Double-blind Cluster-randomized Placebo-controlled Study on the Safety of Integrated Treatment of Trachoma and Lymphatic Filariasis in Children and Adults With Azithromycin, Ivermectin and Albendazole
- ClinicalTrials.gov ID
- NCT01903057
- Acronym / sponsor ID
- AZIVAL2 / IRB00065751
- Conditions
- Trachoma, Lymphatic Filariasis
- Keywords
- Mass Drug Administration, Neglected Tropical Diseases, Preventive Chemotherapy and Transmission Control, Preventive Chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: As of November 2013, the security situation in rural Northern Mozambique is no longer suitable for this clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 19 Jul 2013 (estimated)
- 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.
Trachoma and lymphatic filariasis (LF) are two 'Neglected Tropical Diseases' (NTDs), infectious diseases that affect millions of poor people in countries in the developing world. Trachoma is an eye infection that can lead to painful scarring of the eyelids and blindness later in life. LF can lead to swelling of usually the limbs (elephantiasis).
Trachoma and LF are preventable and treatable diseases. One important treatment strategy is annual Mass Drug Administration (MDA): Communities receive drug treatment once a year. Azithromycin is given for trachoma. Ivermectin and albendazole are given for LF.
Trachoma MDA and LF MDA are currently separated campaigns. Combined MDA campaigns for trachoma and LF, where three drugs would be given at one time, would reduce costs and decrease the burden on the health system.
Before combined MDA with three drugs (azithromycin, ivermectin and albendazole) could be recommended, we would have to demonstrate that the safety profile of this treatment with three drugs is acceptable. An earlier study in Mali in 2010 (AZIVAL) comparing standard MDA (one week space between the two MDA campaigns) with combined MDA (trachoma and LF MDA on the same day) showed that the safety profiles were comparable; but the results of the study were not statistically significant and we could not use them to make an official recommendation.
The AZIVAL 2 study has been designed to answer the questions that remain after the AZIVAL study performed in Mali in 2010. If the safety results of the AZIVAL 2 study are acceptable, an official recommendation for combined MDA with azithromycin, ivermectin and albendazole can be drafted.
We will conduct the AZIVAL 2 study in Mozambique. The target population (inclusion and exclusion criteria) is the same as in the AZIVAL study in Mali. Main criteria are: Age ≥ 5 years and ≤ 65 years, height ≥ 90 cm, if female, not pregnant or breast-feeding.
Important differences between the AZIVAL study and the AZIVAL 2 study are a) smaller clusters for sufficient power (average household size is 5 people), b) placebo to double-blind participants and study staff for azithromycin, c) the study area will have undergone fewer previous rounds of MDA for LF and none for trachoma, and d) smartphones for data entry.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination treatment | Experimental | Drug: azithromycin, Drug: ivermectin, Drug: albendazole, Drug: placeboCombination treatment with azithromycin, ivermectin and albendazole on day 1, followed by placebo on day 8 Placebo has same appearance and dosing as azithromycin. |
| Control (Standard of Care) | Placebo comparator | Drug: azithromycin, Drug: ivermectin, Drug: albendazole, Drug: placeboStandard treatment with placebo, ivermectin and albendazole on day 1, followed by azithromycin on day 8 Placebo has same appearance and dosing as azithromycin. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 5 years and ≤ 65 years.
- Height ≥ 90 cm
- Able to understand the information and consent and assent forms, willing to give consent and assent, and abide by the study restrictions (parent or guardian consent if study participant age is < 18 years, participant to assent form if age < 18 years and ≥ 7 years)
- Residence in the study site for at least three months prior to enrolment
- Willing to remain in the study site for the duration of the study
Key exclusion criteria (6 listed)
- Unable to swallow tablets
- History of hypersensitivity/allergy to azithromycin, ivermectin, and/or albendazole
- Treatment with another investigational agent/intervention within 4 weeks prior to study entry
- Pregnancy (demonstrated by positive urine pregnancy test, performed by study staff, or evidently pregnant). All women of child bearing age (≥ 12 years and ≤ 49 years in Nampula province, personal communication, Arlinda Martins) will undergo a urine pregnancy test (unless they are evidently pregnant) to exclude pregnancy.
- Breast-feeding mother.
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 |
|---|---|---|
| azithromycin | Drug | Combination treatment, Control (Standard of Care) |
| ivermectin | Drug | Combination treatment, Control (Standard of Care) |
| albendazole | Drug | Combination treatment, Control (Standard of Care) |
| placebo | Drug | Combination treatment, Control (Standard of Care) |
Primary outcome
The overall rate of adverse events and serious adverse events in each group
Time frame: 15 days
5 secondary outcomes
The types of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
The incidences of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
The timing of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
The duration of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
The intensities of adverse events and serious adverse events of triple combination therapy with azithromycin, ivermectin and albendazole, to standard sequential therapy.
Time frame: 15 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
- Background: PubMed 23675549Coulibaly YI, Dicko I, Keita M, Keita MM, Doumbia M, Daou A, Haidara FC, Sankare MH, Horton J, Whately-Smith C, Sow SO. A cluster randomized study of the safety of integrated treatment of trachoma and lymphatic filariasis in children and adults in Sikasso, Mali. PLoS Negl Trop Dis. 2013 May 9;7(5):e2221. doi: 10.1371/journal.pntd.0002221. Print 2013.
Related trials for Trachoma
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The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old.
Active Trachoma
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Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Active, not recruitingPhase 4
Kebele Elimination of Trachoma for Ocular Health
Trachoma
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.
Huub C Gelderblom, MD, PhD, MPH principal investigator
Emory University
Ricardo Thompson, PhD principal investigator
Instituto Nacional de Saude, Ministry of Health of Mozambique
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 azithromycin, ivermectin and albendazole in people with Trachoma and Lymphatic Filariasis, run by Emory University at 1 site in Mozambique.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 22 May 2014. 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 Mozambique. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
The overall rate of adverse events and serious adverse events in each group (time frame: 15 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 NCT01903057, 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 22 May 2014.