Community-acquired PneumoniaPhase 4SPARENCT06291012
Stopping Pneumonia Antibiotherapy Regimen Early
A Phase 4 study testing Quick response: Amoxicillin for 3 days, Delayed response: Amoxicillin for 5 days and Quick response: Amoxicillin for 5 days in people with Community-acquired Pneumonia and Child, Only, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to… Read more about this study
- Who is it for?
- Ages 3 to 59 months
- Conditions the study is for
- Community-acquired Pneumonia, Child, Only
- What is being tested?
- Quick response: Amoxicillin for 3 days, Delayed response: Amoxicillin for 5 days and Quick response: Amoxicillin for 5 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 3 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with a diagnosis of community-acquired alveolar pneumonia defined as an association of 3 major criteria + at least 3/5 minor criteria:
- Major criteria: Fever (> 38°C), Polypnea and Chest x-ray
- Minor criteria: Localized crackles, C-Reactive Protein (CRP) > 80mg/L, Alteration of general condition, Cough and Pulmonary condensation syndrome.
- Child with an episode that began less than 7 days before inclusion, in the community.
- Absence of hospitalization criteria
Who cannot join
- Pre-existing underlying pathology: acquired or hereditary immune deficiencies, cardiac pathologies, chronic respiratory failure or pulmonary malformations, neurological or muscular diseases at risk of respiratory decompensation, serious chronic kidney diseases and nephrotic syndromes, sickle cell anemia, diabetes, chronic liver diseases, oncological pathologies and hematological, organ and hematopoietic stem cell transplants, inflammatory and/or autoimmune diseases receiving immunosuppressive treatment, people infected with HIV, obese people with a body mass index (BMI) ≥ the 97th percentile
- Asthma with basic treatment
- Wheezing during the episode
- Presence of pleural effusion on radiography
- Presence of toxin signs
- Antibiotic therapy within 48 hours before inclusion
Show all 15Show fewer
- Anti-inflammatory therapy within 48 hours before inclusion
- Allergy or contraindication to penicillin
- History of more than 2 bacterial pneumonias per year
- Associated infection requiring more than 3 days of antibiotics
- Patient hospitalized within 15 days before inclusion
- Failure to obtain informed consent by the legal representative(s)
- Patient whose legal representatives are unable to read/write french language
- Patient not affiliated with or not benefiting from a national health insurance scheme
- Patient participating in another interventional research involving human person
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carine JAILLET, CRA contact
France1 site
CHU de Montpellier
Montpellier, 34295
Sarah DUTRON, MD
Sarah DUTRON, MD
About this study
Official title: Evaluation of a Therapeutic Strategy to Reduce the Duration of Antibiotic Therapy for Community-acquired Alveolar Pneumonia in Children: a Randomized Controlled Non-inferiority Trial
The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days.
Read the detailed description
Introduction:
The World Health Organization (WHO) has declared antimicrobial resistance to be one of the 10 greatest threats to public health. As such, it has issued recommendations for children for the diagnosis and treatment of pneumonia with amoxicillin for 3 days. However, this strategy includes viral infections and therefore cannot be extrapolated directly to countries with a high level of access to healthcare, where the aim is to treat only bacterial pneumonia and for the shortest possible time to limit the emergence of resistant bacteria. Thus, our study proposes to use a definition of pneumonia adapted to countries with a high level of access to healthcare and to test an adaptive treatment regimen including a clinical reassessment at D3, which will propose a treatment limited to 3 days in case of rapid response and 5 days in case of delayed response.
Aim:
The aim of this trial is to demonstrate the non-inferiority of a strategy of antibiotic treatment with amoxicillin 80-100 mg/kg/day for 3 days in the case of a rapid response or 5 days in the case of a delayed response, versus antibiotic treatment for 5 days in the case of a rapid response or 7 days in the case of a delayed response for the management of non-severe community-acquired alveolar pneumonia in children between 3 and 59 months, in terms of the rate of treatment failure at 7 days.
Methods:
As the hypothesis is not that a shorter antibiotic regimen is more effective in this indication, a non-inferiority trial is the most appropriate design to assess whether this efficacy is broadly comparable with the reference regimen. The primary endpoint chosen is the one already used in an international clinical trial on this disease in children, which has been agreed upon.
In order to meet the objective of the study, 1100 patients will be included.
- At D0, patients will be included and randomized by the investigator, and will begin their treatment: Short arm: treatment by amoxicillin 80-100 mg/kg/d for 3 days if rapid response or 5 days if delayed response; or Long arm: treatment by amoxicillin 80-100 mg/kg/d for 5 days if rapid response or 7 days if delayed response. A prescription and follow-up diary will be given to the family.
- At D3, the doctor will assess the response to the treatment. If the response is assessed as rapid, then the investigator will reduce the duration of antibiotic treatment depending on the arm to which the child has been randomized. Parents will continue to complete the follow-up diary until D7.
- At the D7 visit, the investigator evaluates the primary endpoint and some of the secondary endpoints.
- At the D30 visit, the investigator assesses of last secondary endpoints.
Given the non-inferiority design, data will be analyzed on a per protocol basis for the primary analysis. The per-protocol population will be defined by radiologist of pneumonia diagnosis, at least one dose of amoxicillin, and having primary endpoint assessment data at 7 days. Non-inferiority will be declared if the lower bound of the confidence interval of the difference in failure rate between the 3-day and 5-day arms is less than 3.5%.
- Conditions
- Community-acquired Pneumonia, Child, Only
- Being tested
- Quick response: Amoxicillin for 3 days, Delayed response: Amoxicillin for 5 days, Quick response: Amoxicillin for 5 days, Delayed response: Amoxicillin for 7 days
- Keywords
- Antibiotics management, Amoxicillin
- 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.
Quick response: Amoxicillin for 3 daysDrug
Also called Quick response (3 days)
Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment.
In case of rapid response*: Immediate stop of antibiotherapy (after 9 complete doses)
*A rapid response is determined by a favorable clinical evolution (MASCOT 2002 study)
Delayed response: Amoxicillin for 5 daysDrug
Also called Delayed response (5 days)
Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment.
In case of delayed response: Continuation of antibiotic therapy for up to 5 days
Quick response: Amoxicillin for 5 daysDrug
Also called Quick response (5 days)
Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment.
In case of rapid response*: Continuation of antibiotherapy for up to 5 days
*A rapid response is determined by a favorable clinical evolution (MASCOT 2002 study)
Delayed response: Amoxicillin for 7 daysDrug
Also called Delayed response (7 days)
Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment.
In case of delayed response: Continuation of antibiotic therapy for up to 7 days
| Study group | Role | What they receive |
|---|---|---|
| Short arm | Experimental | Antibiotic therapy for 3 to 5 days depending on response Receives: Drug: Quick response: Amoxicillin for 3 days; Drug: Delayed response: Amoxicillin for 5 days |
| Long arm | Active comparator | Antibiotic therapy for 5 to 7 days depending on response Receives: Drug: Quick response: Amoxicillin for 5 days; Drug: Delayed response: Amoxicillin for 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic failure rate D7
Day 0 (D0) is defined as the 1st day of taking amoxicillin.
The rate of therapeutic failure on day 7 (D7) defined by:
- A change in antibiotherapy necessary before D7 due to a lack of satisfactory clinical response or clinical deterioration of the pneumonia.
- A decision to resume or continue antibiotic therapy after D7 in connection with the pneumonia.
- Hospitalization or death due to clinical deterioration related to community-acquired pneumonia.
This definition is based on that already used in a clinical trial carried out in Israel (6. Greenberg D, Givon-Lavi N, Sadaka Y, Ben-Shimol S, Bar-Ziv J, Dagan R. Short-course Antibiotic Treatment for Community-acquired Alveolar Pneumonia in Ambulatory Children. Pediatr Infect Dis J. 2014 Feb;33(2):136-42).
Measured: Day 7
Secondary outcomes (4)
Therapeutic failure rate on D30
Day 0 (D0) is defined as the 1st day of taking amoxicillin.
Therapeutic failure 30 days after , defined by:
- The occurrence of hospitalization linked to the initial episode.
- An abnormal check-up chest x-ray at 1 month with persistent pneumonia.
- The occurrence of complications of pneumonia (severe sepsis, pleurisy, pulmonary sequelae).
- Relapse, defined by the development of signs of pneumonia 6 to 14 days after the respiratory rate returns to normal.
Measured: Day 30
Adverse effects
Occurrence of adverse effects attributable to antibiotics during and after taking amoxicillin.
Day 0 (D0) is defined as the 1st day of taking amoxicillin.
Measured: Day 0, Day 3, Day 7 and Day 30
Compliance
Compliance is recorded in a monitoring log, completed by the child's family, throughout the duration of antibiotic therapy.
Day 0 (D0) is defined as the 1st day of taking amoxicillin.
Measured: Day 7, or Day 30 in case of therapeutic failure
Duration of antibiotic therapy
The duration of antibiotic therapy is collected in a monitoring log completed by the patients' families, and during the interview at visits on D7 and D30.
Day 0 (D0) is defined as the 1st day of taking amoxicillin.
Measured: Day 7 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Model description
- The randomization will be carried out by minimization with stratification on the investigating center and age (\< 1 year and ≥ 1 year)
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Sarah DUTRON, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291012
- Sponsor's protocol ID
- RECHMPL22_0399
- Other IDs
- 2024-512236-30-00
- Acronym
- SPARE
- Status last verified
- May 2024
- First submitted
- 26 Feb 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haider BA, Saeed MA, Bhutta ZA. Short-course versus long-course antibiotic therapy for non-severe community-acquired pneumonia in children aged 2 months to 59 months. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005976. doi: 10.1002/14651858.CD005976.pub2.
PubMed 18425930Pakistan Multicentre Amoxycillin Short Course Therapy (MASCOT) pneumonia study group. Clinical efficacy of 3 days versus 5 days of oral amoxicillin for treatment of childhood pneumonia: a multicentre double-blind trial. Lancet. 2002 Sep 14;360(9336):835-41. doi: 10.1016/S0140-6736(02)09994-4.
PubMed 12243918Ginsburg AS, Mvalo T, Nkwopara E, McCollum ED, Phiri M, Schmicker R, Hwang J, Ndamala CB, Phiri A, Lufesi N, May S. Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children. N Engl J Med. 2020 Jul 2;383(1):13-23. doi: 10.1056/NEJMoa1912400.
PubMed 32609979Chang AB, Grimwood K. Antibiotics for Childhood Pneumonia - Do We Really Know How Long to Treat? N Engl J Med. 2020 Jul 2;383(1):77-79. doi: 10.1056/NEJMe2016328. No abstract available.
PubMed 32609987Greenberg D, Givon-Lavi N, Sadaka Y, Ben-Shimol S, Bar-Ziv J, Dagan R. Short-course antibiotic treatment for community-acquired alveolar pneumonia in ambulatory children: a double-blind, randomized, placebo-controlled trial. Pediatr Infect Dis J. 2014 Feb;33(2):136-42. doi: 10.1097/INF.0000000000000023.
PubMed 23989106Cohen R, Angoulvant F, Biscardi S, Madhi F, Dubos F, Gillet Y. Antibiotic treatment of lower respiratory tract infections. Arch Pediatr. 2017 Dec;24(12S):S17-S21. doi: 10.1016/S0929-693X(17)30513-4.
PubMed 29290229Gauzit R, Castan B, Bonnet E, Bru JP, Cohen R, Diamantis S, Faye A, Hitoto H, Issa N, Lebeaux D, Lesprit P, Maulin L, Poitrenaud D, Raymond J, Strady C, Varon E, Verdon R, Vuotto F, Welker Y, Stahl JP. Anti-infectious treatment duration: The SPILF and GPIP French guidelines and recommendations. Infect Dis Now. 2021 Mar;51(2):114-139. doi: 10.1016/j.idnow.2020.12.001. Epub 2020 Dec 31. No abstract available.
PubMed 34158156Same RG, Amoah J, Hsu AJ, Hersh AL, Sklansky DJ, Cosgrove SE, Tamma PD. The Association of Antibiotic Duration With Successful Treatment of Community-Acquired Pneumonia in Children. J Pediatric Infect Dis Soc. 2021 Apr 3;10(3):267-273. doi: 10.1093/jpids/piaa055.
PubMed 32525203Leekha S, Terrell CL, Edson RS. General principles of antimicrobial therapy. Mayo Clin Proc. 2011 Feb;86(2):156-67. doi: 10.4065/mcp.2010.0639.
PubMed 21282489Angoulvant F, Cohen R, Doit C, Elbez A, Werner A, Bechet S, Bonacorsi S, Varon E, Levy C. Trends in antibiotic resistance of Streptococcus pneumoniae and Haemophilus influenzae isolated from nasopharyngeal flora in children with acute otitis media in France before and after 13 valent pneumococcal conjugate vaccine introduction. BMC Infect Dis. 2015 Jun 21;15:236. doi: 10.1186/s12879-015-0978-9.
PubMed 26093673Angoulvant F, Levy C, Grimprel E, Varon E, Lorrot M, Biscardi S, Minodier P, Dommergues MA, Hees L, Gillet Y, Craiu I, Zenkhri F, Dubos F, Guen CG, Launay E, Martinot A, Cohen R. Early impact of 13-valent pneumococcal conjugate vaccine on community-acquired pneumonia in children. Clin Infect Dis. 2014 Apr;58(7):918-24. doi: 10.1093/cid/ciu006. Epub 2014 Feb 13.
PubMed 24532543
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Therapeutic Strategy to Reduce the Duration of Antibiotic Therapy for Community-acquired Alveolar Pneumonia in Children: a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06291012
- Acronym / sponsor ID
- SPARE / RECHMPL22_0399
- Conditions
- Community-acquired Pneumonia, Child, Only
- Keywords
- Antibiotics management, Amoxicillin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 Mar 2024 (actual)
- 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 hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days.
Detailed description
Introduction:
The World Health Organization (WHO) has declared antimicrobial resistance to be one of the 10 greatest threats to public health. As such, it has issued recommendations for children for the diagnosis and treatment of pneumonia with amoxicillin for 3 days. However, this strategy includes viral infections and therefore cannot be extrapolated directly to countries with a high level of access to healthcare, where the aim is to treat only bacterial pneumonia and for the shortest possible time to limit the emergence of resistant bacteria. Thus, our study proposes to use a definition of pneumonia adapted to countries with a high level of access to healthcare and to test an adaptive treatment regimen including a clinical reassessment at D3, which will propose a treatment limited to 3 days in case of rapid response and 5 days in case of delayed response.
Aim:
The aim of this trial is to demonstrate the non-inferiority of a strategy of antibiotic treatment with amoxicillin 80-100 mg/kg/day for 3 days in the case of a rapid response or 5 days in the case of a delayed response, versus antibiotic treatment for 5 days in the case of a rapid response or 7 days in the case of a delayed response for the management of non-severe community-acquired alveolar pneumonia in children between 3 and 59 months, in terms of the rate of treatment failure at 7 days.
Methods:
As the hypothesis is not that a shorter antibiotic regimen is more effective in this indication, a non-inferiority trial is the most appropriate design to assess whether this efficacy is broadly comparable with the reference regimen. The primary endpoint chosen is the one already used in an international clinical trial on this disease in children, which has been agreed upon.
In order to meet the objective of the study, 1100 patients will be included.
- At D0, patients will be included and randomized by the investigator, and will begin their treatment: Short arm: treatment by amoxicillin 80-100 mg/kg/d for 3 days if rapid response or 5 days if delayed response; or Long arm: treatment by amoxicillin 80-100 mg/kg/d for 5 days if rapid response or 7 days if delayed response. A prescription and follow-up diary will be given to the family.
- At D3, the doctor will assess the response to the treatment. If the response is assessed as rapid, then the investigator will reduce the duration of antibiotic treatment depending on the arm to which the child has been randomized. Parents will continue to complete the follow-up diary until D7.
- At the D7 visit, the investigator evaluates the primary endpoint and some of the secondary endpoints.
- At the D30 visit, the investigator assesses of last secondary endpoints.
Given the non-inferiority design, data will be analyzed on a per protocol basis for the primary analysis. The per-protocol population will be defined by radiologist of pneumonia diagnosis, at least one dose of amoxicillin, and having primary endpoint assessment data at 7 days. Non-inferiority will be declared if the lower bound of the confidence interval of the difference in failure rate between the 3-day and 5-day arms is less than 3.5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The randomization will be carried out by minimization with stratification on the investigating center and age (< 1 year and ≥ 1 year)
| Arm | Type | Receives |
|---|---|---|
| Short arm | Experimental | Drug: Quick response: Amoxicillin for 3 days, Drug: Delayed response: Amoxicillin for 5 daysAntibiotic therapy for 3 to 5 days depending on response |
| Long arm | Active comparator | Drug: Quick response: Amoxicillin for 5 days, Drug: Delayed response: Amoxicillin for 7 daysAntibiotic therapy for 5 to 7 days depending on response |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child with a diagnosis of community-acquired alveolar pneumonia defined as an association of 3 major criteria + at least 3/5 minor criteria:
- Child with an episode that began less than 7 days before inclusion, in the community.
- Absence of hospitalization criteria
Key exclusion criteria (15 listed)
- Pre-existing underlying pathology: acquired or hereditary immune deficiencies, cardiac pathologies, chronic respiratory failure or pulmonary malformations, neurological or muscular diseases at risk of respiratory decompensation, serious chronic kidney diseases and nephrotic syndromes, sickle cell anemia, diabetes, chronic liver diseases, oncological pathologies and hematological, organ and hematopoietic stem cell transplants, inflammatory and/or autoimmune diseases receiving immunosuppressive treatment, people infected with HIV, obese people with a body mass index (BMI) ≥ the 97th percentile
- Asthma with basic treatment
- Wheezing during the episode
- Presence of pleural effusion on radiography
- Presence of toxin signs
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 |
|---|---|---|
| Quick response: Amoxicillin for 3 daysAlso: Quick response (3 days)Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment. In case of rapid response*: Immediate stop of antibiotherapy (after 9 complete doses) *A rapid response is determined by a favorable clinical evolution (MASCOT 2002 study) | Drug | Short arm |
| Delayed response: Amoxicillin for 5 daysAlso: Delayed response (5 days)Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment. In case of delayed response: Continuation of antibiotic therapy for up to 5 days | Drug | Short arm |
| Quick response: Amoxicillin for 5 daysAlso: Quick response (5 days)Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment. In case of rapid response*: Continuation of antibiotherapy for up to 5 days *A rapid response is determined by a favorable clinical evolution (MASCOT 2002 study) | Drug | Long arm |
| Delayed response: Amoxicillin for 7 daysAlso: Delayed response (7 days)Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment. In case of delayed response: Continuation of antibiotic therapy for up to 7 days | Drug | Long arm |
Primary outcome
Therapeutic failure rate D7
Time frame: Day 7
Day 0 (D0) is defined as the 1st day of taking amoxicillin. The rate of therapeutic failure on day 7 (D7) defined by: * A change in antibiotherapy necessary before D7 due to a lack of satisfactory clinical response or clinical deterioration of the pneumonia. * A decision to resume or continue antibiotic therapy after D7 in connection with the pneumonia. * Hospitalization or death due to clinical deterioration related to community-acquired pneumonia. This definition is based on that already used in a clinical trial carried out in Israel (6. Greenberg D, Givon-Lavi N, Sadaka Y, Ben-Shimol S, Bar-Ziv J, Dagan R. Short-course Antibiotic Treatment for Community-acquired Alveolar Pneumonia in Ambulatory Children. Pediatr Infect Dis J. 2014 Feb;33(2):136-42).
4 secondary outcomes
Therapeutic failure rate on D30
Time frame: Day 30
Adverse effects
Time frame: Day 0, Day 3, Day 7 and Day 30
Compliance
Time frame: Day 7, or Day 30 in case of therapeutic failure
Duration of antibiotic therapy
Time frame: Day 7 and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Background: PubMed 18425930Haider BA, Saeed MA, Bhutta ZA. Short-course versus long-course antibiotic therapy for non-severe community-acquired pneumonia in children aged 2 months to 59 months. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005976. doi: 10.1002/14651858.CD005976.pub2.
- Background: PubMed 12243918Pakistan Multicentre Amoxycillin Short Course Therapy (MASCOT) pneumonia study group. Clinical efficacy of 3 days versus 5 days of oral amoxicillin for treatment of childhood pneumonia: a multicentre double-blind trial. Lancet. 2002 Sep 14;360(9336):835-41. doi: 10.1016/S0140-6736(02)09994-4.
- Background: PubMed 32609979Ginsburg AS, Mvalo T, Nkwopara E, McCollum ED, Phiri M, Schmicker R, Hwang J, Ndamala CB, Phiri A, Lufesi N, May S. Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children. N Engl J Med. 2020 Jul 2;383(1):13-23. doi: 10.1056/NEJMoa1912400.
- Background: PubMed 32609987Chang AB, Grimwood K. Antibiotics for Childhood Pneumonia - Do We Really Know How Long to Treat? N Engl J Med. 2020 Jul 2;383(1):77-79. doi: 10.1056/NEJMe2016328. No abstract available.
- Background: PubMed 23989106Greenberg D, Givon-Lavi N, Sadaka Y, Ben-Shimol S, Bar-Ziv J, Dagan R. Short-course antibiotic treatment for community-acquired alveolar pneumonia in ambulatory children: a double-blind, randomized, placebo-controlled trial. Pediatr Infect Dis J. 2014 Feb;33(2):136-42. doi: 10.1097/INF.0000000000000023.
- Background: PubMed 29290229Cohen R, Angoulvant F, Biscardi S, Madhi F, Dubos F, Gillet Y. Antibiotic treatment of lower respiratory tract infections. Arch Pediatr. 2017 Dec;24(12S):S17-S21. doi: 10.1016/S0929-693X(17)30513-4.
- Background: PubMed 34158156Gauzit R, Castan B, Bonnet E, Bru JP, Cohen R, Diamantis S, Faye A, Hitoto H, Issa N, Lebeaux D, Lesprit P, Maulin L, Poitrenaud D, Raymond J, Strady C, Varon E, Verdon R, Vuotto F, Welker Y, Stahl JP. Anti-infectious treatment duration: The SPILF and GPIP French guidelines and recommendations. Infect Dis Now. 2021 Mar;51(2):114-139. doi: 10.1016/j.idnow.2020.12.001. Epub 2020 Dec 31. No abstract available.
- Background: PubMed 32525203Same RG, Amoah J, Hsu AJ, Hersh AL, Sklansky DJ, Cosgrove SE, Tamma PD. The Association of Antibiotic Duration With Successful Treatment of Community-Acquired Pneumonia in Children. J Pediatric Infect Dis Soc. 2021 Apr 3;10(3):267-273. doi: 10.1093/jpids/piaa055.
- Background: PubMed 21282489Leekha S, Terrell CL, Edson RS. General principles of antimicrobial therapy. Mayo Clin Proc. 2011 Feb;86(2):156-67. doi: 10.4065/mcp.2010.0639.
- Background: PubMed 26093673Angoulvant F, Cohen R, Doit C, Elbez A, Werner A, Bechet S, Bonacorsi S, Varon E, Levy C. Trends in antibiotic resistance of Streptococcus pneumoniae and Haemophilus influenzae isolated from nasopharyngeal flora in children with acute otitis media in France before and after 13 valent pneumococcal conjugate vaccine introduction. BMC Infect Dis. 2015 Jun 21;15:236. doi: 10.1186/s12879-015-0978-9.
- Background: PubMed 24532543Angoulvant F, Levy C, Grimprel E, Varon E, Lorrot M, Biscardi S, Minodier P, Dommergues MA, Hees L, Gillet Y, Craiu I, Zenkhri F, Dubos F, Guen CG, Launay E, Martinot A, Cohen R. Early impact of 13-valent pneumococcal conjugate vaccine on community-acquired pneumonia in children. Clin Infect Dis. 2014 Apr;58(7):918-24. doi: 10.1093/cid/ciu006. Epub 2014 Feb 13.
- WHO declared antimicrobial resistance one of the 10 biggest public health threats facing humanityLink provided by the sponsor.
- ANSM: All committed to better use of antibiotics (2021, November)Link provided by the sponsor.
- Review on antimicrobial resistance. Tackling drug-resistant infections globally: Final report and recommendations. (2016 May)Link provided by the sponsor.
- General principles and advice for prescribing antibiotics as a first resort (2014, February)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Carine JAILLET, CRA contact
Sarah DUTRON, MD study director
University Hospital, Montpellier
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 Quick response: Amoxicillin for 3 days, Delayed response: Amoxicillin for 5 days and Quick response: Amoxicillin for 5 days in people with Community-acquired Pneumonia and Child, Only, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 15 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: opening soon, as of the sponsor's last update on 20 May 2024. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah DUTRON, MD (+334.67.33.66.34, s-dutron@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic failure rate D7 (time frame: Day 7). 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 NCT06291012, which also lists 11 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 May 2024; AzTrials last refreshed its copy on 26 Oct 2026.