BronchitisNCT02879981
A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis
An observational study of Bronchitis, run by Hoffmann-La Roche at 3 sites in Peru.
Trial summary
This pilot, multicentric and observational study will assess the safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute bronchitis. Administration of treatment will be according to treating physician's recommendation under local labeling. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Bronchitis
- What is being tested?
- Guaifenesin, Sulfamethoxazole and Trimethoprim
- How many people
- 51 participants
- Where
- 3 sitesPeru
- Study dates
- 10 Nov 2016to 28 Aug 2017
- Phase
- Observational
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric participants receiving treatment for acute bronchitis with Balsamic Bactrim according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling and who have no contraindication to Balsamic Bactrim as per the local label.
Who may be able to join
- Participants starting treatment with Bactrim Balsamic suspension
- Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the medical criteria
Who cannot join
- Participants who have started treatment with another antibiotic at the time of the visit
- Participants with no respiratory infections
- Participants with mental disorders that do not permit the clinical evaluation of the participant according to the treating physician's criteria
- Participants with severe hepatic parenchymal damage
- Participants with severe renal failure making it difficult to monitor drug plasma concentration
- Participants with hypersensitivity to any of Balsamic Bactrim active ingredients, excipients, and/or sulfas
Trial locations and contacts
3 sites in 1 country.
Peru3 sites
Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica
La Victoria, 15033
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, Lima 41
Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA
San Isidro, 27
About this study
Official title: A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Pediatric Patients With Acute Bronchitis
This pilot, multicentric and observational study will assess the safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute bronchitis. Administration of treatment will be according to treating physician's recommendation under local labeling.
- Conditions
- Bronchitis
- Being tested
- Guaifenesin, Sulfamethoxazole, Trimethoprim
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuaifenesinDrug
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
SulfamethoxazoleDrug
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
TrimethoprimDrug
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Participants With Acute Bronchitis | Pediatric participants receiving treatment for acute bronchitis with Balsamic Bactrim according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling and who have no contraindication to Balsamic Bactrim as per the local label will be observed for safety. Receives: Drug: Guaifenesin; Drug: Sulfamethoxazole; Drug: Trimethoprim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by Treating Physician
Measured: From Day 1 up to end of observation (up to 10 days)
Secondary outcomes (8)
Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease)
Measured: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change
Measured: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration
Measured: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Dose Interruption
Measured: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Treatment Discontinuation
Measured: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation
Measured: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician
Measured: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific predefined factors, these will be decided based on observations during study)
Measured: From Day 1 up to end of observation (up to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start10 Nov 2016
- Primary completion28 Aug 2017
- Study completion28 Aug 2017
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 BronchitisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879981
- Sponsor's protocol ID
- ML30017
- Status last verified
- Dec 2019
- First submitted
- 23 Aug 2016
- Last updated
- 13 Dec 2019
- Results posted
- No
Publications
Falcon M, Iberico C, Guerra F, Reyes I, Felix E, Flores M, de Los Rios J, Diaz ME, Casas A, Sanchez-Gambetta S, Carrasco R. A pilot study of safety of sulfamethoxazole, trimethoprim and guaifenesin in pediatric and adult patients with acute bronchitis. BMC Res Notes. 2019 Mar 4;12(1):119. doi: 10.1186/s13104-019-4150-2.
PubMed 30832720
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Pediatric Patients With Acute Bronchitis
- ClinicalTrials.gov ID
- NCT02879981
- Acronym / sponsor ID
- ML30017
- Conditions
- Bronchitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 28 Aug 2017 (actual)
- Study completion
- 28 Aug 2017 (actual)
- First posted
- 26 Aug 2016 (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.
This pilot, multicentric and observational study will assess the safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute bronchitis. Administration of treatment will be according to treating physician's recommendation under local labeling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Participants With Acute Bronchitis | – | Drug: Guaifenesin, Drug: Sulfamethoxazole, Drug: TrimethoprimPediatric participants receiving treatment for acute bronchitis with Balsamic Bactrim according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling and who have no contraindication to Balsamic Bactrim as per the local label will be observed for safety. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric participants receiving treatment for acute bronchitis with Balsamic Bactrim according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling and who have no contraindication to Balsamic Bactrim as per the local label.
Key inclusion criteria (2 listed)
- Participants starting treatment with Bactrim Balsamic suspension
- Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the medical criteria
Key exclusion criteria (6 listed)
- Participants who have started treatment with another antibiotic at the time of the visit
- Participants with no respiratory infections
- Participants with mental disorders that do not permit the clinical evaluation of the participant according to the treating physician's criteria
- Participants with severe hepatic parenchymal damage
- Participants with severe renal failure making it difficult to monitor drug plasma concentration
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 |
|---|---|---|
| GuaifenesinAdministration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen. | Drug | Pediatric Participants With Acute Bronchitis |
| SulfamethoxazoleAdministration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen. | Drug | Pediatric Participants With Acute Bronchitis |
| TrimethoprimAdministration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen. | Drug | Pediatric Participants With Acute Bronchitis |
Primary outcome
Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by Treating Physician
Time frame: From Day 1 up to end of observation (up to 10 days)
8 secondary outcomes
Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease)
Time frame: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change
Time frame: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration
Time frame: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Dose Interruption
Time frame: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Treatment Discontinuation
Time frame: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation
Time frame: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician
Time frame: From Day 1 up to end of observation (up to 10 days)
Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific predefined factors, these will be decided based on observations during study)
Time frame: From Day 1 up to end of observation (up to 10 days)
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 13 Dec 2019.
- Derived from this study: PubMed 30832720Falcon M, Iberico C, Guerra F, Reyes I, Felix E, Flores M, de Los Rios J, Diaz ME, Casas A, Sanchez-Gambetta S, Carrasco R. A pilot study of safety of sulfamethoxazole, trimethoprim and guaifenesin in pediatric and adult patients with acute bronchitis. BMC Res Notes. 2019 Mar 4;12(1):119. doi: 10.1186/s13104-019-4150-2.
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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.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchitis, run by Hoffmann-La Roche at 3 sites in Peru.
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 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: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Peru. 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?
Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by Treating Physician (time frame: From Day 1 up to end of observation (up to 10 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 NCT02879981, 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 13 Dec 2019.