Community-Acquired PneumoniaPhase 4NCT01166932
Comparison Between Amoxycillin/Clavulanic Acid and Oxacillin/Ceftriaxone for Community Acquired-pneumonia
A Phase 4 study testing Amoxycillin/clavulanic acid and ceftriaxone/oxacillin in people with Community-Acquired Pneumonia, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
Objective: To compare the clinical effectiveness and hospital costs, the initial empirical treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community Acquired Pneumonia (CAP) severe. Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Community-Acquired Pneumonia
- What is being tested?
- Amoxycillin/clavulanic acid and ceftriaxone/oxacillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2005to Apr 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged from 2 months to 5 years
- children diagnosed with severe community-acquired pneumonia, who require hospitalization.
Who cannot join
- chronical diseases
- severe comorbidities
- children admitted at PICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF CLINICAL EFFICACY OF COMBINATION Amoxycillin Plus Clavulanic Acid and Oxacillin Plus Ceftriaxone for HOSPITAL TREATMENT OF COMMUNITY Acquired PNEUMONIA IN CHILDREN : A Randomized Clinical Study
Objective: To compare the clinical effectiveness and hospital costs, the initial empirical treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community Acquired Pneumonia (CAP) severe.
Methods: Clinical prospective randomized study in children aged two months to five years of age with a diagnosis of severe CAP, according to criteria of World Health Organization (WHO), admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu- UNESP. We excluded children with comorbid disorders (primary and secondary immunodeficiency) with acute or chronic kidney disease, referred patients receiving antibiotics proposal and history of allergy to antibiotics proposed. We included 104 children who were randomized into two groups to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin / Clavulanate IV (GAA, n = 56). Patients of the GAA, after clinical improvement, has been receiving the same oral antibiotic, and maintaining clinical stability, were discharged from hospital, the GOC received any IV treatment. The outcomes analyzed were time to clinical improvement (fever and tachypnea), duration of oxygen therapy, hospitalization time, need to expand the antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and hospital costs. Treatment failure was determined by the need to expand the antimicrobial spectrum after 48 hours of hospitalization.
Read the detailed description
eligibility: Children aged two months to five years with diagnosis of severe community acquired pneumonia, requiring hospitalization.
Outcomes measures: time to clinical improvement (respiratory rate and fever), duration of oxygen therapy, length of stay in the Division of Pediatrics, evolution with clinical complications, need for broadening the spectrum antimicrobials.
- Conditions
- Community-Acquired Pneumonia
- Being tested
- Amoxycillin/clavulanic acid, ceftriaxone/oxacillin
- Keywords
- pneumonia, children, antibiotics
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxycillin/clavulanic acidDrug
100mg/Kg/day/10 days.
ceftriaxone/oxacillinDrug
75 mg/Kg/day/10 days.
| Study group | Role | What they receive |
|---|---|---|
| amoxicillin/clavulanic acid | Active comparator | patients who received amoxicillin/clavulanic acid Receives: Drug: Amoxycillin/clavulanic acid |
| ceftriaxone/oxacillin | Active comparator | Not described Receives: Drug: ceftriaxone/oxacillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay at pediatric ward.
Measured: 3 years
Secondary outcomes (1)
need for broadening the spectrum antimicrobials.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startApr 2005
- Primary completionApr 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Cristiane F Ribeiro, MD, Principal investigator, UNESP - Botucatu Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166932
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-44
- Status last verified
- Oct 2010
- First submitted
- 11 May 2010
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ribeiro CF, Ferrari GF, Fioretto JR. Antibiotic treatment schemes for very severe community-acquired pneumonia in children: a randomized clinical study. Rev Panam Salud Publica. 2011 Jun;29(6):444-50.
PubMed 21829969
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF CLINICAL EFFICACY OF COMBINATION Amoxycillin Plus Clavulanic Acid and Oxacillin Plus Ceftriaxone for HOSPITAL TREATMENT OF COMMUNITY Acquired PNEUMONIA IN CHILDREN : A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01166932
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-44
- Conditions
- Community-Acquired Pneumonia
- Keywords
- pneumonia, children, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To compare the clinical effectiveness and hospital costs, the initial empirical treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community Acquired Pneumonia (CAP) severe.
Methods: Clinical prospective randomized study in children aged two months to five years of age with a diagnosis of severe CAP, according to criteria of World Health Organization (WHO), admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu- UNESP. We excluded children with comorbid disorders (primary and secondary immunodeficiency) with acute or chronic kidney disease, referred patients receiving antibiotics proposal and history of allergy to antibiotics proposed. We included 104 children who were randomized into two groups to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin / Clavulanate IV (GAA, n = 56). Patients of the GAA, after clinical improvement, has been receiving the same oral antibiotic, and maintaining clinical stability, were discharged from hospital, the GOC received any IV treatment. The outcomes analyzed were time to clinical improvement (fever and tachypnea), duration of oxygen therapy, hospitalization time, need to expand the antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and hospital costs. Treatment failure was determined by the need to expand the antimicrobial spectrum after 48 hours of hospitalization.
Detailed description
eligibility: Children aged two months to five years with diagnosis of severe community acquired pneumonia, requiring hospitalization.
Outcomes measures: time to clinical improvement (respiratory rate and fever), duration of oxygen therapy, length of stay in the Division of Pediatrics, evolution with clinical complications, need for broadening the spectrum antimicrobials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amoxicillin/clavulanic acid | Active comparator | Drug: Amoxycillin/clavulanic acidpatients who received amoxicillin/clavulanic acid |
| ceftriaxone/oxacillin | Active comparator | Drug: ceftriaxone/oxacillin |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged from 2 months to 5 years
- children diagnosed with severe community-acquired pneumonia, who require hospitalization.
Key exclusion criteria (3 listed)
- chronical diseases
- severe comorbidities
- children admitted at PICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxycillin/clavulanic acid100mg/Kg/day/10 days. | Drug | amoxicillin/clavulanic acid |
| ceftriaxone/oxacillin75 mg/Kg/day/10 days. | Drug | ceftriaxone/oxacillin |
Primary outcome
length of stay at pediatric ward.
Time frame: 3 years
1 secondary outcome
need for broadening the spectrum antimicrobials.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
- Derived from this study: PubMed 21829969Ribeiro CF, Ferrari GF, Fioretto JR. Antibiotic treatment schemes for very severe community-acquired pneumonia in children: a randomized clinical study. Rev Panam Salud Publica. 2011 Jun;29(6):444-50.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristiane F Ribeiro, MD principal investigator
UNESP - Botucatu Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amoxycillin/clavulanic acid and ceftriaxone/oxacillin in people with Community-Acquired Pneumonia, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay at pediatric ward. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01166932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2010.