Parasitic DiseasesAZIVALNCT01586169
Safety of the Co-administration of Three Drugs for Trachoma and Lymphatic Filariasis Elimination
A study testing triple co administration at once of the combination of Albendazole + ivermectin + azithromycin in people with Parasitic Diseases and Bacterial Diseases, run by Centre d'Appui à la lutte contre la Maladie at 1 site in Mali.
Trial summary
The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic… Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Parasitic Diseases, Bacterial Diseases
- What is being tested?
- triple co administration at once of the combination of Albendazole + ivermectin + azithromycin
- How many people
- 3,000 participants
- Where
- 1 siteMali
- Study dates
- Feb 2010to Feb 2010
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must have been residing in the village for at least three months;
- Must be 90 cm tall or more;
- Must be between 5 years and 65 years of age;
- Must not be pregnant;
- Must not be lactating.
Who cannot join
- Subjects under 5 years of age or less than 90 cm in height;
- Subjects over 65 years of age;
- Subjects who cannot swallow tablets;
- Subjects who are sick and bedridden;
- Pregnant women (clinical appreciation in the study);
- Lactating women;
- History of allergies to the drugs being studied (azithromycin, ivermectin, albendazole).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacovigilance Study on the Safety of Integrated Treatment of Trachoma and Lymphatic Filariasis in Children and Adults Living in the Sikasso Region of Mali
The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic filariasis and trachoma.
Read the detailed description
Infectious diseases such as trachoma and lymphatic filariasis are public health problems in regions of Africa and Asia. Elimination programs exist for the two diseases, and their treatment by different groups of health workers is both costly and inefficient.
Thus, a study evaluating the safety and feasibility of an integrated mass treatment of trachoma and lymphatic filariasis with azithromycin associated with albendazole and ivermectin was instituted in 4 villages of the region of Sikasso in Mali (West Africa) co endemic for lymphatic filariasis and trachoma.
It was an open label randomized clusters type on the assessment of the safety of the triple co administration of azithromycin, ivermectin and albendazole (experimental regimen) as compared to the administration of the co administration of albendazole plus ivermectin followed by the that of azithromycin a week later (current standard recommended regimen) within subjects of 5 to 65 years old, willing and able to swallow the study drugs.
Clinical evaluation of adverse events in all study participants was done on day 0, day 8, and day 15 after the treatment.
- Conditions
- Parasitic Diseases, Bacterial Diseases
- Being tested
- triple co administration at once of the combination of Albendazole + ivermectin + azithromycin
- Keywords
- Albendazole, Ivermectin, Azithromycin, Lymphatic filariasis, Trachoma, Safety
- Medical subject headings
- Parasitic Diseases, Bacterial Infections, Elephantiasis, Filarial, Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple co administration at once of the combination of Albendazole + ivermectin + azithromycinDrug
Also called Albendazole, Mectizan, Zithromax
Albendazole 400mg + ivermectin according to the height + azithromycin according to the height at once
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the incidence of adverse events associated with the mass triple drug administration
Measured: From Day 0 to Day 15 post treatment
Secondary outcomes (1)
Establish the incidence of serious adverse events associated with the mass triple drug administration
Measured: From Day 0 to Day 15 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startFeb 2010
- Primary completionFeb 2010
- Study completionFeb 2010
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 Parasitic DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Appui à la lutte contre la Maladie
- Sponsor type
- University, hospital or other
- Collaborators
- International Trachoma Initiative
- Responsible party
- Sponsor
- Investigators
- Samba O Sow, MD, MPH, Principal investigator, CNAM, Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586169
- Sponsor's protocol ID
- CNAM/AZIVAL/01
- Other IDs
- 0958/FMPOS
- Acronym
- AZIVAL
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 26 Apr 2012
- 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 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacovigilance Study on the Safety of Integrated Treatment of Trachoma and Lymphatic Filariasis in Children and Adults Living in the Sikasso Region of Mali
- ClinicalTrials.gov ID
- NCT01586169
- Acronym / sponsor ID
- AZIVAL / CNAM/AZIVAL/01
- Conditions
- Parasitic Diseases, Bacterial Diseases
- Keywords
- Albendazole, Ivermectin, Azithromycin, Lymphatic filariasis, Trachoma, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Centre d'Appui à la lutte contre la MaladieUniversity, hospital or other
- Collaborators
- International Trachoma Initiative
- Study start
- Feb 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Apr 2012 (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.
The purpose of this study is to determine whether the triple co administration of albendazole, ivermectin and azithromycine is as safe as the current treatment scheme that consists to treat with albendazole plus ivermectin together and a week later to treat with azithromycin in areas co endemic for lymphatic filariasis and trachoma.
Detailed description
Infectious diseases such as trachoma and lymphatic filariasis are public health problems in regions of Africa and Asia. Elimination programs exist for the two diseases, and their treatment by different groups of health workers is both costly and inefficient.
Thus, a study evaluating the safety and feasibility of an integrated mass treatment of trachoma and lymphatic filariasis with azithromycin associated with albendazole and ivermectin was instituted in 4 villages of the region of Sikasso in Mali (West Africa) co endemic for lymphatic filariasis and trachoma.
It was an open label randomized clusters type on the assessment of the safety of the triple co administration of azithromycin, ivermectin and albendazole (experimental regimen) as compared to the administration of the co administration of albendazole plus ivermectin followed by the that of azithromycin a week later (current standard recommended regimen) within subjects of 5 to 65 years old, willing and able to swallow the study drugs.
Clinical evaluation of adverse events in all study participants was done on day 0, day 8, and day 15 after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Must have been residing in the village for at least three months;
- Must be 90 cm tall or more;
- Must be between 5 years and 65 years of age;
- Must not be pregnant;
- Must not be lactating.
Key exclusion criteria (7 listed)
- Subjects under 5 years of age or less than 90 cm in height;
- Subjects over 65 years of age;
- Subjects who cannot swallow tablets;
- Subjects who are sick and bedridden;
- Pregnant women (clinical appreciation in the study);
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 |
|---|---|---|
| triple co administration at once of the combination of Albendazole + ivermectin + azithromycinAlso: Albendazole, Mectizan, ZithromaxAlbendazole 400mg + ivermectin according to the height + azithromycin according to the height at once | Drug | – |
Primary outcome
Establish the incidence of adverse events associated with the mass triple drug administration
Time frame: From Day 0 to Day 15 post treatment
1 secondary outcome
Establish the incidence of serious adverse events associated with the mass triple drug administration
Time frame: From Day 0 to Day 15 post treatment
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 26 Apr 2012.
- Derived from this study: 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.
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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.
Samba O Sow, MD, MPH principal investigator
CNAM, Mali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triple co administration at once of the combination of Albendazole + ivermectin + azithromycin in people with Parasitic Diseases and Bacterial Diseases, run by Centre d'Appui à la lutte contre la Maladie at 1 site in Mali.
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 5 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 26 Apr 2012. 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 Mali. 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.
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?
Establish the incidence of adverse events associated with the mass triple drug administration (time frame: From Day 0 to Day 15 post treatment). 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 NCT01586169, 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 26 Apr 2012.