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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-063-20
Enrollment
362
Registered
2020-11-30
Start date
2021-01-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

Cefalexina + Ambroxol Type of group
Bacterial pharyngitis, tonsillitis, streptococcal infections of the nasopharynx, acute otitis media and in general in the treatment of bronchopulmonary processes or sensitive germs that occur with increase viscosity and adherence of mucus. Pharmaceutical form and route of administration: Powder for Oral Suspension. Orally Route of administration: 25-50 mg / kg / day of Cephalexin divided into three doses every 8 hours. Maximum dose: 4 g / day. Group name:Cefalexina Type of grou
Bacterial pharyngitis, tonsillitis, streptococcal infections of the nasopharynx, acute otitis media and in general in the treatment of bronchopulmonary processes or sensitive germs that occur with increase viscosity and adherence of mucus. Pharmaceutical form and route of administration: Powder for Oral Suspension. Orally Route of administration: 25-50 mg / kg / day of Cephalexin divided into three doses every 8 hours. Maximum dose: 4 g / 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. - SARS COV-2 Negative 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:Clinical evaluation by the Norby et al GABHS symptom Assessment Scale for pharyngotonsillitis, and the microbiological evaluation by the rapid antigenic detection test for GABHS Measure:Assess efficacy of BIOBRONCOL® (Cephalexin + Ambroxol) Powder for Oral Suspension in the treatment of acute pharyngotonsillitis. Timepoints:3rd, 11th and 15th days—

Secondary

MeasureTime frame
Outcome name:Norrby et al scale Measure:Early resolution of symptoms in a patient with acute pharyngotonsillitis on day 3 Timepoints:3rd day—

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)