Last updated: 04/18/2025 06:10:48
A prospective and observational study in Vietnam – APPRAISE StudyAPPRAISE
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Antibiotic treatment Patterns and outcomes in adult Patients with either acute bacterial Rhinosinusitis (ABRS) or community-Acquired pneumonia (CAP) In an outpatient setting: A prospective, two-center, observational Study in ViEtnam – APPRAISE Study
Trial description: This study will be conducted to analyze clinical response, treatment patterns, safety, and microbiological outcomes of antibiotic treatments under real-world conditions in participants prescribed with different antibiotic treatments for ABRS or CAP in an outpatient setting in Vietnam. AUGMENTIN is a registered trademark of the GlaxoSmithKline [GSK] group of companies.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with complete resolution of clinical symptoms/signs or improvement of symptoms/signs
Timeframe: Up to 28 days
Number of participants with worsening or non-improvement of clinical symptoms/signs of ABRS or CAP while on antibiotic treatment
Timeframe: Up to 28 days
Number of participants with modifications in the index antibiotic treatment regimen, including treatment extension and/or dose change
Timeframe: Up to 28 days
Number of participants requiring antibiotic treatment switch or add on to the prescribed treatment
Timeframe: Up to 28 days
Number of participants with CAP requiring hospitalization due to worsening of disease
Timeframe: Up to 28 days
Secondary outcomes:
Summary of antibiotic treatments patterns
Timeframe: Up to 28 days
Hospitalization rate of participants treated for CAP
Timeframe: Up to 28 days
Number of participants with microbiological assessments
Timeframe: Up to 28 days
Types of samples collected from participants with CAP or ABRS
Timeframe: Up to 28 days
Bacterial identification including different pathogens isolated
Timeframe: Up to 28 days
Microbiological susceptibility to different antibiotic treatments
Timeframe: Up to 28 days
Association between antibiotic susceptibility and response to treatment
Timeframe: Up to 28 days
Number of antibiotic-related treatment-emergent adverse events (TEAEs)
Timeframe: Up to 28 days
Number of participants with adverse events (AEs) and serious AEs (SAEs)
Timeframe: Up to 28 days
Number of participants with AEs leading to discontinuation
Timeframe: Up to 28 days
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-06-06
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infections, Bacterial
Product
amoxicillin/clavulanic acid
Collaborators
Not applicable
Study date(s)
January 2023 to June 2023
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants with age 18 years or older.
- Clinical diagnosis of ABRS defined as having at least three of the following symptoms/signs: discolored discharge, severe (unilateral dominance) facial pain, high fever (greater than [>]38 degrees Celsius), double sickening, and raised erythrocyte sedimentation rate/C-reactive protein as per physician’s assessment managed in an outpatient setting. Symptoms/signs for ABRS can also include nasal blockage, nasal discharge or impaired smell and symptoms/signs from nasal endoscopy (mucopurulent discharge/and or edema) or clinical diagnosis of mild-to-moderate (defined as having a (confusion, uremia, respiratory rate, low blood pressure, age 65 years or greater [CURB-65] score of less than 2) CAP based on clinical findings (X-rays) and signs/symptoms such as cough and at least one of the following:new focal chest signs, fever persisting for more than four days, dyspnea or tachypnea without other obvious cause as per physician’s assessment managed in an outpatient setting.
- Symptom duration of more than four weeks for ABRS or CAP.
- Use of antibiotics for any indication other than ABRS within four weeks prior to study enrollment.
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with age 18 years or older.
- Clinical diagnosis of ABRS defined as having at least three of the following symptoms/signs: discolored discharge, severe (unilateral dominance) facial pain, high fever (greater than [>]38 degrees Celsius), double sickening, and raised erythrocyte sedimentation rate/C-reactive protein as per physician’s assessment managed in an outpatient setting. Symptoms/signs for ABRS can also include nasal blockage, nasal discharge or impaired smell and symptoms/signs from nasal endoscopy (mucopurulent discharge/and or edema) or clinical diagnosis of mild-to-moderate (defined as having a (confusion, uremia, respiratory rate, low blood pressure, age 65 years or greater [CURB-65] score of less than 2) CAP based on clinical findings (X-rays) and signs/symptoms such as cough and at least one of the following:new focal chest signs, fever persisting for more than four days, dyspnea or tachypnea without other obvious cause as per physician’s assessment managed in an outpatient setting.
- Treated with antibiotics for clinical management of ABRS or CAP: initiate an antibiotic treatment as per physician’s prescription for ABRS or CAP (i.e., participants have not received any prior antibiotic treatment) or initiate a new antibiotic treatment as per physician’s prescription for ABRS (i.e., participants may have received a prior antibiotic treatment up to seven days before enrollment in the study) or continue with an antibiotic treatment initiated up to seven days before enrollment in the study, with modifications to the treatment regimen (i.e., dosing, frequency, etc.) as per physician’s prescription for ABRS.
- Provision of participant consent or legal representative as relevant.
Exclusion criteria:
- Symptom duration of more than four weeks for ABRS or CAP.
- Use of antibiotics for any indication other than ABRS within four weeks prior to study enrollment.
- Ventilator-associated or hospital-acquired pneumonia.
- Concomitant condition precluding evaluation of clinical response, such as acute mastoiditis, facial palsy, bacterial meningitis, malignancy, and cardiac disease.
- Participating in a clinical trial at the time of enrollment and during the study period.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2023-06-06
Actual study completion date
2023-06-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
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