PediculosesIVERAZITHNCT03578679
Treatment of Pediculosis (Head Lice) in Senegal
A study testing Ivermectin Oral Product in people with Pediculoses, run by Institut de Recherche pour le Developpement at 1 site in Senegal.
Trial summary
This is a prospective single-arm interventional study evaluating Therapeutic efficacy of a combination of two pharmaceutical drugs, Azithromycin (AZIT) and Ivermectin (IVER) administered orally in the treatment of head lice infestations. Read more about this study
- Who is it for?
- Ages 6 years and older, women only
- Conditions the study is for
- Pediculoses
- What is being tested?
- Ivermectin Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSenegal
- Study dates
- 11 Jul 2018to 24 Feb 2019
- 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 6 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Includes lists of Inclusion Criteria:
- body weight ≥ 15 kg for oral administration to ivermectin, • Obtain the signed informed consent of the parent or caregiver for his participation in the study.
Includes lists of Criteria Exclusion:
- Refusal of participation,
- Non-residents in the villages during the study period,
- body weight <15 kg not eligible for oral administration with ivermectin,
- Pregnant women, who in the context of the daily medical and epidemiological monitoring of the population of Dielmo-like that of Ndiop- are identified and very early at the looking at the first signs of conception in a pregnant woman from her state of pregnancy on the basis of a proven test. In addition, before any treatment with ivermectin, will be systematically requested from each of the target women of reproductive age if she is pregnant
- Women breastfeeding at the time of the study,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Therapeutic Efficacy of the Combination Azithromycin + Ivermectin in the Treatment of Pediculosis in Senegal (IVERAZITH)
This is a prospective single-arm interventional study evaluating Therapeutic efficacy of a combination of two pharmaceutical drugs, Azithromycin (AZIT) and Ivermectin (IVER) administered orally in the treatment of head lice infestations. In case of persistence of lice and / or nits on day 7, a second oral administration of combination Azithromycin + Ivermectin will be considered.
The duration of the study period is 4 months, ie 1 month and ½ of inclusion and 2 months and ½ feedback. There will be a site initiation visit "site initiation visit" before inclusions at D-7, two monitoring visits and a closing visit "close out visit" at the end of the follow-up at 4 months.
Read the detailed description
The investigators will perform a clinical trial of efficacy, single-arm, until D28 from volunteer subjects infested with head lice.
The two villages of the study (Dielmo and Ndiop) will be visited to explain the protocol and obtain community permission to work on it. Schools will also be visited to inform teachers and explain the protocol. The search for lice will be done by village women recruited for this purpose. A systematic census by family will be performed. A clinical examination of the hair will detect the persons infested with lice. On D-1, individual informed consent (an assent for participants between the ages of 15 and 18) will be systematically obtained before inclusion.
At D1, an interview and a complete clinical examination will be done on each subject consenting. All volunteers meeting the inclusion criteria will be taken on a single arms. For each voluntary participant selected fasting 1 hour before, the treatments will be administered by the investigators of the study. After taking the AZIT + IVER dose, each treated volunteer will be followed for 1 hour to observe the appearance of any side effects, then a breakfast will be offered. Head lice and nits will be searched on D1, D7, D15 and D28 for each volunteer and the hair taken on D2, D5, D7, D15 and D28. Possibly, before each treatment, Stool samples will be taken systematically on day 1 and after treatment on day 15 at any participant infested with head lice to identify intestinal parasites (load parasite in helminthiasis) to evaluate also the efficacy of ivermectin on these parasites. Sociodemographic, clinical, dose and type of material taken biological will be documented. Data on co-infections (body lice, Sarcoptes scabeii) will also be collected and reported on the study register. Each volunteer will have an identification number (ID). Only, the principal investigator, the coordinator and the investigators can access sensitive information if they exist. Data will be entered immediately by a data entry agent. The investigators will sleep on the sites and will face possible cases of effects undesirable. Regular visits will be scheduled on D2, D5, D7, D15 and D28. A clinical monitor will stay with the team on the field of D2, D5, D7, D15 and D28. A Clinical Research Organisation (CRO) will ensure the external monitoring of the study (1 site initiation visit, 2 monitoring visits and 1 visit closing of the test). It will also be scheduled for a visit by Comité National d'Ethique en Santé (CNERS) members on the field according to their schedule. All willing participants and completing the eligibility criteria for entry into this study, will be taken on a single treatment arm Azithromycin-Ivermectin in orodispersible tablets. The evaluation of the answer therapy will be done on D7 and / or D15.
- Conditions
- Pediculoses
- Being tested
- Ivermectin Oral Product
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin Oral ProductDrug
Also called Azithromycine oral Product
treatment of pediculosis (head lice)
| Study group | Role | What they receive |
|---|---|---|
| HEGOR/AZICUR shampoo solution | Experimental | At D1, shampoo AZICUR liquid formulation in infested persons aged 0 to 6 years and / or less than 15 kg, also apply the combination HEGOR / AZICUR solution shampoo in women pregnant or lactating women not eligible for treatment with Ivermectin, to prevent them from contaminate treated participants who are very close to them or share the same bed or same bench table at school. Receives: Drug: Ivermectin Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasiticidal efficacy: disappearance of head lice (zero lice) on day 7
Evaluating the efficacy of the treatment of combination of two usual drugs from volunteer subjects infested with head lice.
To study the therapeutic efficacy of the combination Azithromycin-Ivermectin administered orally in the treatment of head lice infestations (in case of persistence of lice at D7 a second oral administration of the combination azithromycin-Ivermectin will be considered).
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start11 Jul 2018
- Primary completion31 Jan 2019
- Study completion24 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediculosesStudies 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
- Model description
- Interventional prospective study with only one arm
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cheikh Sokhna, PhD, Study director, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578679
- Sponsor's protocol ID
- SEN17/16
- Acronym
- IVERAZITH
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: oral communications and publications
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Therapeutic Efficacy of the Combination Azithromycin + Ivermectin in the Treatment of Pediculosis in Senegal (IVERAZITH)
- ClinicalTrials.gov ID
- NCT03578679
- Acronym / sponsor ID
- IVERAZITH / SEN17/16
- Conditions
- Pediculoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 24 Feb 2019 (actual)
- First posted
- 6 Jul 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 prospective single-arm interventional study evaluating Therapeutic efficacy of a combination of two pharmaceutical drugs, Azithromycin (AZIT) and Ivermectin (IVER) administered orally in the treatment of head lice infestations. In case of persistence of lice and / or nits on day 7, a second oral administration of combination Azithromycin + Ivermectin will be considered.
The duration of the study period is 4 months, ie 1 month and ½ of inclusion and 2 months and ½ feedback. There will be a site initiation visit "site initiation visit" before inclusions at D-7, two monitoring visits and a closing visit "close out visit" at the end of the follow-up at 4 months.
Detailed description
The investigators will perform a clinical trial of efficacy, single-arm, until D28 from volunteer subjects infested with head lice.
The two villages of the study (Dielmo and Ndiop) will be visited to explain the protocol and obtain community permission to work on it. Schools will also be visited to inform teachers and explain the protocol. The search for lice will be done by village women recruited for this purpose. A systematic census by family will be performed. A clinical examination of the hair will detect the persons infested with lice. On D-1, individual informed consent (an assent for participants between the ages of 15 and 18) will be systematically obtained before inclusion.
At D1, an interview and a complete clinical examination will be done on each subject consenting. All volunteers meeting the inclusion criteria will be taken on a single arms. For each voluntary participant selected fasting 1 hour before, the treatments will be administered by the investigators of the study. After taking the AZIT + IVER dose, each treated volunteer will be followed for 1 hour to observe the appearance of any side effects, then a breakfast will be offered. Head lice and nits will be searched on D1, D7, D15 and D28 for each volunteer and the hair taken on D2, D5, D7, D15 and D28. Possibly, before each treatment, Stool samples will be taken systematically on day 1 and after treatment on day 15 at any participant infested with head lice to identify intestinal parasites (load parasite in helminthiasis) to evaluate also the efficacy of ivermectin on these parasites. Sociodemographic, clinical, dose and type of material taken biological will be documented. Data on co-infections (body lice, Sarcoptes scabeii) will also be collected and reported on the study register. Each volunteer will have an identification number (ID). Only, the principal investigator, the coordinator and the investigators can access sensitive information if they exist. Data will be entered immediately by a data entry agent. The investigators will sleep on the sites and will face possible cases of effects undesirable. Regular visits will be scheduled on D2, D5, D7, D15 and D28. A clinical monitor will stay with the team on the field of D2, D5, D7, D15 and D28. A Clinical Research Organisation (CRO) will ensure the external monitoring of the study (1 site initiation visit, 2 monitoring visits and 1 visit closing of the test). It will also be scheduled for a visit by Comité National d'Ethique en Santé (CNERS) members on the field according to their schedule. All willing participants and completing the eligibility criteria for entry into this study, will be taken on a single treatment arm Azithromycin-Ivermectin in orodispersible tablets. The evaluation of the answer therapy will be done on D7 and / or D15.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional prospective study with only one arm
| Arm | Type | Receives |
|---|---|---|
| HEGOR/AZICUR shampoo solution | Experimental | Drug: Ivermectin Oral ProductAt D1, shampoo AZICUR liquid formulation in infested persons aged 0 to 6 years and / or less than 15 kg, also apply the combination HEGOR / AZICUR solution shampoo in women pregnant or lactating women not eligible for treatment with Ivermectin, to prevent them from contaminate treated participants who are very close to them or share the same bed or same bench table at school. |
Who may qualify
- Ages
- 6 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Ivermectin Oral ProductAlso: Azithromycine oral Producttreatment of pediculosis (head lice) | Drug | HEGOR/AZICUR shampoo solution |
Primary outcome
Parasiticidal efficacy: disappearance of head lice (zero lice) on day 7
Time frame: Day 7
Evaluating the efficacy of the treatment of combination of two usual drugs from volunteer subjects infested with head lice. To study the therapeutic efficacy of the combination Azithromycin-Ivermectin administered orally in the treatment of head lice infestations (in case of persistence of lice at D7 a second oral administration of the combination azithromycin-Ivermectin will be considered).
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 27 Feb 2019.
- Individual participant dataSharing planned: Undecided. oral communications and publications
Related trials for Pediculoses
Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice
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.
Cheikh Sokhna, PhD study director
Institut de Recherche pour le Developpement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivermectin Oral Product in people with Pediculoses, run by Institut de Recherche pour le Developpement at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 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 Senegal. 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?
Parasiticidal efficacy: disappearance of head lice (zero lice) on day 7 (time frame: Day 7). 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 27 Feb 2019.