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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica | La Victoria | 15033 | Peru | |||
| Clinica Internacional, Sede San Borja; Unidad de Investigacion de ClĂnica Internacional |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30832720 | Derived | 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. |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D006140 | Guaifenesin |
| D013420 | Sulfamethoxazole |
| D014295 | Trimethoprim |
| ID | Term |
|---|---|
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010647 |
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| 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. |
|
| 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. |
|
| 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) |
| Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation | 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 | 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) | From Day 1 up to end of observation (up to 10 days) |
| Lima |
| Lima 41 |
| Peru |
| ClĂnica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA | San Isidro | 27 | Peru |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| Phenyl Ethers |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |