BronchiolitisPhase 2NCT02452905
Finding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments
A Phase 2 study testing Nitazoxanide in people with Bronchiolitis, run by Telethon Kids Institute at 1 site in Australia.
Trial summary
Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral infection.This study evaluates whether treatment with nitazoxanide (NTZ) reduces the duration and severity of respiratory symptoms caused by bronchiolitis. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2016to Jul 2018
- Phase
- Phase 2
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged greater than or equal to 1 month to less than or equal to 12 months
- Diagnosed with bronchiolitis by the assessing doctor
- Parent/legally responsible carer has provided informed consent for their infant/child to participate in the study
- Parent/legally responsible carer able and willing to comply with the requirements of the protocol
- Parent/legally responsible carer willing to attend a study follow up visit on study day 3 if their infant/child has previously been discharged from hospital
- Parent/legally responsible carer willing to allow other parties involved in the treatment of his or her child (including the general practitioner, paediatrician, hospital medical and nursing staff, community clinic staff) to be notified of participation in the trial
- Infants and children whose parent is willing to allow the study team to obtain an interim medical history from the participants electronic medical records (including immunisation records) and/or from the participants general practitioner or other medical professional for the period from enrolment to study day 180
Who cannot join
- Presence of symptoms of bronchiolitis (breathing difficulty, difficulty feeding, cough, poor feeding) for greater than or equal to 48 hours at the time of enrolment
- Born at gestational age of less than 32 weeks
- Has a history of any condition associated with risk of severe bronchiolitis including (significant cardiovascular disease, including congenital heart disease, significant respiratory disease including chronic lung disease, Trisomy 21, significant neurological disease including history of seizure disorder, significant impairment/alteration of the immune system including congenital immunodeficiency or any other disorder considered relevant by a medically qualified investigator
- Requiring admission to intensive care unit at enrolment
- Clinical suspicion of illness other than bronchiolitis
- Contraindication to the study drug or placebo (hypersensitivity), medical treatment with medication which in the opinion of the admitting team would make the child unsuitable for the study
Show all 13Show fewer
- Receipt of investigational drug/vaccine, other than the drugs used in the study within 30 days prior to receiving the first dose of NTZ or their planned use during the study period until 1 month after the administration of the final dose of NTZ
- Previously enrolled in the study
- Parent less than 18 years of age
- TEMPORARY EXCLUSION CRITERIA
- Receipt of an anti-viral medication within the previous 7 days
- Inability to tolerate either the oral or nasogastric route (e.g. ileus)
- Any systemic corticosteroid (or equivalent) treatment in 14 days prior to enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Double-blind Randomised, Placebo-controlled Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments
Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral infection.This study evaluates whether treatment with nitazoxanide (NTZ) reduces the duration and severity of respiratory symptoms caused by bronchiolitis. Half of the participants will receive NTZ while the other half will receive a placebo.
Read the detailed description
Nitazoxanide (NTZ) is a novel anti-infective medication that is licenced for use in the United States (US), including in children and infants for treating some infections. It is in the thiazolide class of antimicrobials and has been shown to have in vitro and/or clinical activity against a broad spectrum of pathogens, including a range of viruses, parasites and bacteria.
This study will determine whether NTZ is an effective empirical treatment for bronchiolitis. It will also help us to understand what effect NTZ has on the amount of virus present and how viral load changes over the course of the disease. If this study shows that NTZ is a useful treatment, then a larger study will be conducted enrolling infants that present to primary care facilities.
- Conditions
- Bronchiolitis
- Being tested
- Nitazoxanide, Placebo (for Nitazoxanide)
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Alinia
Placebo (for Nitazoxanide)Drug
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Active comparator | Nitazoxanide 7.5mg/kg oral/nasogastric/nasoenteric tube three times per day for five days. Receives: Drug: Nitazoxanide |
| Placebo | Placebo comparator | The placebo is identical to the active drug described above except that it does not contain the active compound nitazoxanide. It is reconstitutes, administered and dosed as per the active study drug. Receives: Drug: Placebo (for Nitazoxanide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of respiratory distress
The calculation of a Respiratory Assessment Change Score (RACS) by the use of the Respiratory Distress Assessment Instrument (RDAI) from baseline (day 1) to study day 4 adjusted for the standardised change in respiratory rate with points being assigned by change increments of 10% Internal reliability and responsiveness of the RACS as a measure of respiratory distress in infants has been previously demonstrated and it correlates well with other measures of respiratory distress
Measured: Up to day 4
Secondary outcomes (6)
Nasopharyngeal excretion of Respiratory Syncytial Virus (RSV)
The change in nasopharyngeal viral excretion as measured by Polymerase Chain Reaction (PCR)
Measured: Up to 72 hours
Duration of parent reported solicited symptoms associated with bronchiolitis during and after treatment
The time until the severity of ALL solicited symptoms associated with bronchiolitis (loss of appetite, activity level, respiratory effort and irritability) have first been assessed as mild or normal from the day of randomisation to the end of study day 7
Measured: Up to day 7
Actual duration of hospital admission for any reason
The period of time for which hospitalisation is required for any medical reason
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 to 3 days.
Need for interventional supportive medical care
The use of oxygen therapy, supportive ventilation, admission to the Intensive Care Unit (ICU) and supportive hydration therapy (NG or IV). Duration of use is calculated from the calendar day of randomisation to the date of cessation
Measured: Up to day 7
Severity of parent reported solicited symptoms associated with bronchiolitis during and after treatment
The time until the severity of ALL solicited symptoms associated with bronchiolitis (loss of appetite, activity level, respiratory effort and irritability) have first been assessed as mild or normal from the day of randomisation to the end of study day 7
Measured: Up to day 7
Duration of interventional supportive medical care
The use of oxygen therapy, supportive ventilation, admission to the Intensive Care Unit (ICU) and supportive hydration therapy (NG or IV). Duration of use is calculated from the calendar day of randomisation to the date of cessation
Measured: Up to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startDec 2016
- Primary completionOct 2017 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: The drug manufacture were unable to produce liquid formulation of the IMP within a reasonable time frame so the funding was relinquished.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire WADDINGTON, BMBS MSc MRCP (UK) DPhil, Principal investigator, Telethon Kids Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452905
- Sponsor's protocol ID
- CVID/2014-02
- Status last verified
- Oct 2017
- First submitted
- 12 May 2015
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-blind Randomised, Placebo-controlled Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments
- ClinicalTrials.gov ID
- NCT02452905
- Acronym / sponsor ID
- CVID/2014-02
- Conditions
- Bronchiolitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The drug manufacture were unable to produce liquid formulation of the IMP within a reasonable time frame so the funding was relinquished.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Telethon Kids InstituteUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 25 May 2015 (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.
Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral infection.This study evaluates whether treatment with nitazoxanide (NTZ) reduces the duration and severity of respiratory symptoms caused by bronchiolitis. Half of the participants will receive NTZ while the other half will receive a placebo.
Detailed description
Nitazoxanide (NTZ) is a novel anti-infective medication that is licenced for use in the United States (US), including in children and infants for treating some infections. It is in the thiazolide class of antimicrobials and has been shown to have in vitro and/or clinical activity against a broad spectrum of pathogens, including a range of viruses, parasites and bacteria.
This study will determine whether NTZ is an effective empirical treatment for bronchiolitis. It will also help us to understand what effect NTZ has on the amount of virus present and how viral load changes over the course of the disease. If this study shows that NTZ is a useful treatment, then a larger study will be conducted enrolling infants that present to primary care facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Active comparator | Drug: NitazoxanideNitazoxanide 7.5mg/kg oral/nasogastric/nasoenteric tube three times per day for five days. |
| Placebo | Placebo comparator | Drug: Placebo (for Nitazoxanide)The placebo is identical to the active drug described above except that it does not contain the active compound nitazoxanide. It is reconstitutes, administered and dosed as per the active study drug. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged greater than or equal to 1 month to less than or equal to 12 months
- Diagnosed with bronchiolitis by the assessing doctor
- Parent/legally responsible carer has provided informed consent for their infant/child to participate in the study
- Parent/legally responsible carer able and willing to comply with the requirements of the protocol
- Parent/legally responsible carer willing to attend a study follow up visit on study day 3 if their infant/child has previously been discharged from hospital
Key exclusion criteria (13 listed)
- Presence of symptoms of bronchiolitis (breathing difficulty, difficulty feeding, cough, poor feeding) for greater than or equal to 48 hours at the time of enrolment
- Born at gestational age of less than 32 weeks
- Has a history of any condition associated with risk of severe bronchiolitis including (significant cardiovascular disease, including congenital heart disease, significant respiratory disease including chronic lung disease, Trisomy 21, significant neurological disease including history of seizure disorder, significant impairment/alteration of the immune system including congenital immunodeficiency or any other disorder considered relevant by a medically qualified investigator
- Requiring admission to intensive care unit at enrolment
- Clinical suspicion of illness other than bronchiolitis
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 |
|---|---|---|
| NitazoxanideAlso: Alinia | Drug | Nitazoxanide |
| Placebo (for Nitazoxanide) | Drug | Placebo |
Primary outcome
Severity of respiratory distress
Time frame: Up to day 4
The calculation of a Respiratory Assessment Change Score (RACS) by the use of the Respiratory Distress Assessment Instrument (RDAI) from baseline (day 1) to study day 4 adjusted for the standardised change in respiratory rate with points being assigned by change increments of 10% Internal reliability and responsiveness of the RACS as a measure of respiratory distress in infants has been previously demonstrated and it correlates well with other measures of respiratory distress
6 secondary outcomes
Nasopharyngeal excretion of Respiratory Syncytial Virus (RSV)
Time frame: Up to 72 hours
Duration of parent reported solicited symptoms associated with bronchiolitis during and after treatment
Time frame: Up to day 7
Actual duration of hospital admission for any reason
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 to 3 days.
Need for interventional supportive medical care
Time frame: Up to day 7
Severity of parent reported solicited symptoms associated with bronchiolitis during and after treatment
Time frame: Up to day 7
Duration of interventional supportive medical care
Time frame: Up to day 7
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 12 Oct 2017.
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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.
Claire WADDINGTON, BMBS MSc MRCP (UK) DPhil principal investigator
Telethon Kids Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide in people with Bronchiolitis, run by Telethon Kids Institute at 1 site in Australia.
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 7 inclusion and 13 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 12 Oct 2017. 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 Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Severity of respiratory distress (time frame: Up to day 4). 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 12 Oct 2017.