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Influence of Bacterial Growing Properties in Treatment of Acute Exacerbation Chronic Sinusitis

Influence of Bacterial Biofilms in Clinical Treatment of Patients with Acute Exacerbation Chronic Rhinossinusitis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-4twfv7
Enrollment
Unknown
Registered
2015-04-17
Start date
2013-03-17
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Chronic rhinosinusitis

Interventions

Experimental group: 11 subjects treated with nasal washing with 0,9% saline and amoxicillin/clavulanate tablets each 8 hour for 14 days. Control group: 11 subjects treated with nasal washing with 0,9%
Drug
Behavioural
D02.065.589.099.374.160.060

Sponsors

Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Subjects of both genders, adults (older than 18 years) routine followed by outpatient management with clinical signs and symptoms compatible with acute exacerbation of chronic rhinosinusitis. Voluntarily agree to participate in the study and signed an informed consent and informed.

Exclusion criteria

Exclusion criteria: Patients who have used oral or topical antibiotics in the last 30 days; systemic corticosteroids in the past 30 days, who are using systemic antihistamine, systemic or topical decongestants. Patients younger than 18 years, pregnant women, patients with allergy to any component of amoxicillin-clavulanate or carrying any serious disease.

Design outcomes

Primary

MeasureTime frame
Expected: To evaluate whether antibiotic therapy modifies the evolution of acute exacerbation of chronic sinusitis and if there is a relationship between the clinical condition and the presence of a biofilm-forming bacteria by comparisson of questionnaires daily symptoms, quality of life scores, nasal endoscopy and the detection of biofilm forming bacteria in nasal swab cultures by Calgary modified assay.;Found: Different methods of evaluation were concordant that patients treated with amoxicillin-clavulanate had clinical improvement, although there was no bacteriological cure at the end of treatment in most cases. Higher frequency of exacerbation and bad clinical outcome were associated with biofilm-forming bacteria.

Secondary

MeasureTime frame
Expected: To identify the prevalence of biofilm-forming bacteria in patients with acute exacerbation chronic rhinosinusitis and to compare the difference between minimum inhibitory concentration to antibiotics of planktonic forms and inhibitory concentration of biofilms to antibiotics of biofilm-forming bacteria by Calgary modified assay.;Found: Inhibitory concentration for biofilm-forming bacteria showed high rates of resistance to amoxicillin and clarithromycin for gram-negative bacteria, although amoxicillin-clavulanate and levofloxacin were effective inhibiting the growth of all bacteria.

Countries

Brazil

Contacts

Public ContactHenrique Sabino

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

hensabino@yahoo.com.br+55(16)-8146-0806

Outcome results

None listed

Source: REBEC (via WHO ICTRP)