A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis
NCT ID: NCT02879981
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2016-11-10
2017-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Guaifenesin
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Sulfamethoxazole
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Trimethoprim
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Interventions
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Guaifenesin
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Sulfamethoxazole
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Trimethoprim
Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
Eligibility Criteria
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Inclusion Criteria
* Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the medical criteria
Exclusion Criteria
* 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
4 Years
14 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica
La Victoria, , Peru
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, , Peru
Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA
San Isidro, , Peru
Countries
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References
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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.
Other Identifiers
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ML30017
Identifier Type: -
Identifier Source: org_study_id