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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02879981
Other study ID # ML30017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 10, 2016
Est. completion date August 28, 2017

Study information

Verified date December 2019
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date August 28, 2017
Est. primary completion date August 28, 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 14 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Peru 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

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Peru, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Adverse Events Related to Balsamic Bactrim as Assessed by Treating Physician From Day 1 up to end of observation (up to 10 days)
Secondary Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease) From Day 1 up to end of observation (up to 10 days)
Secondary Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change From Day 1 up to end of observation (up to 10 days)
Secondary Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration From Day 1 up to end of observation (up to 10 days)
Secondary Percentage of Participants With Balsamic Bactrim Dose Interruption From Day 1 up to end of observation (up to 10 days)
Secondary Percentage of Participants With Balsamic Bactrim Treatment Discontinuation From Day 1 up to end of observation (up to 10 days)
Secondary Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation From Day 1 up to end of observation (up to 10 days)
Secondary Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician From Day 1 up to end of observation (up to 10 days)
Secondary Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific predefined factors, these will be decided based on observations during study) From Day 1 up to end of observation (up to 10 days)
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