Community-acquired PneumoniaPhase 4PNEUMOPACEfNCT01200706
Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Pneumonia
A Phase 4 study testing Amoxicillin in people with Community-acquired Pneumonia, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or three times a day to children with non-severe community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2006to May 2011
- 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 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 2 and 59 months
- Report of respiratory complaints
- Presence of pulmonary infiltrate on chest x-ray taken on admission and read by the pediatrician on duty
Who cannot join
- lower chest indrawing
- danger signs (inability to drink, convulsions, somnolence, central cyanosis, grunting in a calm child)
- diagnosed underlying chronic diseases (anatomic abnormalities of the respiratory tract, chronic pulmonary illness besides asthma, immunological defects, progressing neurological disorders, psychomotor retardation, heart disease with clinical repercussion, hemoglobinopathy, liver or kidney disease)
- severe malnutrition
- other concurrent infection
- hospitalization during the previous 7 days
Show all 9Show fewer
- amoxicillin or similar antibiotic use during the last 48 hours
- allergy to amoxicillin
- history of aspiration
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Professor Hosannah de Oliveira Pediatric Center
Salvador, Estado de Bahia, 40160-170
About this study
Official title: Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Community-acquired Pneumonia
The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or three times a day to children with non-severe community-acquired pneumonia.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Amoxicillin
- Keywords
- children aged under 5 years, Non-severe
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Placebo with amoxicillin,in the opposite posologic scheme
amoxicillin 50mg/kg/day given in two different administration schemes
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin given twice a day | Active comparator | Not described Receives: Drug: Amoxicillin |
| Amoxicillin given three times a day | Active comparator | Not described Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical efficacy
resolution of fever, difficulty breathing and tachypnea
Measured: 48 hours
Secondary outcomes (1)
Resolution of cough
Disappearance of cough
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startNov 2006
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Investigators
- Cristiana M Nascimento-Carvalho, MD, PhD, Principal investigator, Federal University of Bahia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200706
- Sponsor's protocol ID
- APR0127/2006
- Acronym
- PNEUMOPACEf
- Status last verified
- Sep 2010
- First submitted
- 13 Sep 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nascimento-Carvalho AC, Vilas-Boas AL, Fontoura MH, Vuorinen T, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. Respiratory viruses among children with non-severe community-acquired pneumonia: A prospective cohort study. J Clin Virol. 2018 Aug;105:77-83. doi: 10.1016/j.jcv.2018.06.003. Epub 2018 Jun 6.
PubMed 29908521Nascimento-Carvalho AC, Vilas-Boas AL, Fontoura MH, Xu M, Vuorinen T, Soderlund-Venermo M, Ruuskanen O, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. Serologically diagnosed acute human bocavirus 1 infection in childhood community-acquired pneumonia. Pediatr Pulmonol. 2018 Jan;53(1):88-94. doi: 10.1002/ppul.23891. Epub 2017 Oct 13.
PubMed 29028159Nascimento-Carvalho CM, Xavier-Souza G, Vilas-Boas AL, Fontoura MH, Barral A, Puolakkainen M, Ruuskanen O; PNEUMOPAC-Efficacy Study Group. Evolution of acute infection with atypical bacteria in a prospective cohort of children with community-acquired pneumonia receiving amoxicillin. J Antimicrob Chemother. 2017 Aug 1;72(8):2378-2384. doi: 10.1093/jac/dkx126.
PubMed 28475737Vilas-Boas AL, Fontoura MS, Xavier-Souza G, Araujo-Neto CA, Andrade SC, Brim RV, Noblat L, Barral A, Cardoso MR, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial. J Antimicrob Chemother. 2014 Jul;69(7):1954-9. doi: 10.1093/jac/dku070. Epub 2014 Mar 19.
PubMed 24648506Xavier-Souza G, Vilas-Boas AL, Fontoura MS, Araujo-Neto CA, Andrade SC, Cardoso MR, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. The inter-observer variation of chest radiograph reading in acute lower respiratory tract infection among children. Pediatr Pulmonol. 2013 May;48(5):464-9. doi: 10.1002/ppul.22644. Epub 2012 Aug 8.
PubMed 22888091
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT01200706
- Acronym / sponsor ID
- PNEUMOPACEf / APR0127/2006
- Conditions
- Community-acquired Pneumonia
- Keywords
- children aged under 5 years, Non-severe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Sep 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.
The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or three times a day to children with non-severe community-acquired pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin given twice a day | Active comparator | Drug: Amoxicillin |
| Amoxicillin given three times a day | Active comparator | Drug: Amoxicillin |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 2 and 59 months
- Report of respiratory complaints
- Presence of pulmonary infiltrate on chest x-ray taken on admission and read by the pediatrician on duty
Key exclusion criteria (9 listed)
- lower chest indrawing
- danger signs (inability to drink, convulsions, somnolence, central cyanosis, grunting in a calm child)
- diagnosed underlying chronic diseases (anatomic abnormalities of the respiratory tract, chronic pulmonary illness besides asthma, immunological defects, progressing neurological disorders, psychomotor retardation, heart disease with clinical repercussion, hemoglobinopathy, liver or kidney disease)
- severe malnutrition
- other concurrent infection
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 |
|---|---|---|
| AmoxicillinAlso: Placebo with amoxicillin,in the opposite posologic schemeamoxicillin 50mg/kg/day given in two different administration schemes | Drug | Amoxicillin given three times a day, Amoxicillin given twice a day |
Primary outcome
clinical efficacy
Time frame: 48 hours
resolution of fever, difficulty breathing and tachypnea
1 secondary outcome
Resolution of cough
Time frame: 96 hours
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 20 Jul 2011.
- Derived from this study: PubMed 29908521Nascimento-Carvalho AC, Vilas-Boas AL, Fontoura MH, Vuorinen T, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. Respiratory viruses among children with non-severe community-acquired pneumonia: A prospective cohort study. J Clin Virol. 2018 Aug;105:77-83. doi: 10.1016/j.jcv.2018.06.003. Epub 2018 Jun 6.
- Derived from this study: PubMed 29028159Nascimento-Carvalho AC, Vilas-Boas AL, Fontoura MH, Xu M, Vuorinen T, Soderlund-Venermo M, Ruuskanen O, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. Serologically diagnosed acute human bocavirus 1 infection in childhood community-acquired pneumonia. Pediatr Pulmonol. 2018 Jan;53(1):88-94. doi: 10.1002/ppul.23891. Epub 2017 Oct 13.
- Derived from this study: PubMed 28475737Nascimento-Carvalho CM, Xavier-Souza G, Vilas-Boas AL, Fontoura MH, Barral A, Puolakkainen M, Ruuskanen O; PNEUMOPAC-Efficacy Study Group. Evolution of acute infection with atypical bacteria in a prospective cohort of children with community-acquired pneumonia receiving amoxicillin. J Antimicrob Chemother. 2017 Aug 1;72(8):2378-2384. doi: 10.1093/jac/dkx126.
- Derived from this study: PubMed 24648506Vilas-Boas AL, Fontoura MS, Xavier-Souza G, Araujo-Neto CA, Andrade SC, Brim RV, Noblat L, Barral A, Cardoso MR, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. Comparison of oral amoxicillin given thrice or twice daily to children between 2 and 59 months old with non-severe pneumonia: a randomized controlled trial. J Antimicrob Chemother. 2014 Jul;69(7):1954-9. doi: 10.1093/jac/dku070. Epub 2014 Mar 19.
- Derived from this study: PubMed 22888091Xavier-Souza G, Vilas-Boas AL, Fontoura MS, Araujo-Neto CA, Andrade SC, Cardoso MR, Nascimento-Carvalho CM; PNEUMOPAC-Efficacy Study Group. The inter-observer variation of chest radiograph reading in acute lower respiratory tract infection among children. Pediatr Pulmonol. 2013 May;48(5):464-9. doi: 10.1002/ppul.22644. Epub 2012 Aug 8.
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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.
Cristiana M Nascimento-Carvalho, MD, PhD principal investigator
Federal University of Bahia School of Medicine
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 Amoxicillin in people with Community-acquired Pneumonia, run by Federal University of Bahia 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 3 inclusion and 9 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 20 Jul 2011. 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?
clinical efficacy (time frame: 48 hours). 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 NCT01200706, which also lists 5 linked publications.
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 20 Jul 2011.