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MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND CLINICAL TRIAL OF SUPERIORITY IN EFFICACY AND SAFETY OF THE FIXED-DOSE COMBINATION OF AMOXICILLIN AND AMBROXOL (AMBROXIL®) VERSUS AMOXICILLIN IN THE TREATMENT OF ACUTE BACTERIAL PHARYNGITIS IN THE PEDIATRIC POPULATION.

MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND CLINICAL TRIAL OF SUPERIORITY IN EFFICACY AND SAFETY OF THE FIXED-DOSE COMBINATION OF AMOXICILLIN AND AMBROXOL (AMBROXIL®) VERSUS AMOXICILLIN IN THE TREATMENT OF ACUTE BACTERIAL PHARYNGITIS IN THE PEDIATRIC POPULATION.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-062-20
Enrollment
292
Registered
2020-11-30
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

AMOXICILLIN + AMBROXOL POWDER FOR ORAL SUSPENSION Type of group
Pharmaceutical Form and route of administration: Powder for Oral Suspension. Orally Treatment Dosage and Frequencies: 50 mg / kg / day divided into two doses every 12 hours. Maximum dose: 1 g / day. Group name:AMOXICILIN POWDER FOR ORAL SUSPENSION Type of group
TREATMENT OF UPPER AND LOWER RESPIRATORY INFECTIONS CAUSED BY SENSITIVE GERMS. POWDER FOR ORAL SUSPENSION 50ML/KG/DAY DIVIDED INTO 2 DOSES EVERY 12 HOURS. MAXIMUM 1G/DAY

Sponsors

Instituto Quimioterapico S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients between 2 - 15 years - Clinical diagnosis of bacterial pharyngotonsillitis (4 or more McIsaac Modified Centor criteria) with rapid antigenic detection test for positive or negative GABHS, or less than 4 McIsaac Modified Centor criteria with positive GABHS rapid antigenic detection test. - Signed informed consent form. - Negative SARS COV-2 Rapid Test

Exclusion criteria

Exclusion criteria: - Concomitant respiratory infections such as acute otitis media, acute sinusitis, pneumonia, subpharyngeal infections or tonsillar abscesses. - History of rheumatic heart disease or valve dysfunction of unknown etiology - Immunosuppression - Skin rash - Compromise of kidney or liver function. - Patients with some type of cancer. - History of recurrent or recent pharyngotonsillitis (more than 3 episodes in the last 6 months or 1 episode in the last month) - Have received oral antibiotics in the last 7 days prior to enrollment in the study or have received cephalosporins in the last three months. - History of hypersensitivity to amoxicillin or type 1 hypersensitivity to penicillin. - History of hypersensitivity to ambroxol. - Pregnancy or lactation. - Concurrent treatment with another antibiotic or with corticosteroids.

Design outcomes

Primary

MeasureTime frame
Outcome name:Norrby GABHS Symptom Assessment Scale for Pharyngotonsillitis. Rapid antigenic detection test for GABHS. Measure:Improved clinical evaluation and microbiological cure Timepoints:10 and 15 days

Secondary

MeasureTime frame
Outcome name:Symptom assessment scale for GABHS pharyngotonsillitis Measure: Improved clinical evaluation of symptom Timepoints:3 day ; Outcome name:EAS report Measure:EAS rnumbers Timepoints:to 15 days

Countries

Peru

Contacts

Public ContactRAUL YEPEZ

PERUVIAN CLINICAL RESEARCH S.A.C

R.YEPEZ@PCR.PE999962145

Outcome results

None listed

Source: REPEC (via WHO ICTRP)