A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis

NCT02879981 | Completed

• 1 other identifier: ML30017
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Bronchitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease)

  From Day 1 up to end of observation (up to 10 days)

• Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change

  From Day 1 up to end of observation (up to 10 days)

• Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration

  From Day 1 up to end of observation (up to 10 days)

• Percentage of Participants With Balsamic Bactrim Dose Interruption

  From Day 1 up to end of observation (up to 10 days)

• Percentage of Participants With Balsamic Bactrim Treatment Discontinuation

  From Day 1 up to end of observation (up to 10 days)

Study Arms (1)

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.

Drug: Guaifenesin; Drug: Sulfamethoxazole; Drug: Trimethoprim

Interventions

Guaifenesin DRUG

Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

Pediatric Participants With Acute Bronchitis

Sulfamethoxazole DRUG

Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

Pediatric Participants With Acute Bronchitis

Trimethoprim DRUG

Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.

Pediatric Participants With Acute Bronchitis

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica

La Victoria, 15033, Peru

Location

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

Lima, Lima 41, Peru

Location

Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA

San Isidro, 27, Peru

Location

Related Publications (1)

• 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.

  PMID: 30832720 DERIVED

MeSH Terms

Conditions

Bronchitis

Interventions

Guaifenesin; Sulfamethoxazole; Trimethoprim

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Guaiacol; Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: November 10, 2016
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

PE (3)