Child, Only Clinical Trial
— SPAREOfficial 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.
Status | Not yet recruiting |
Enrollment | 1100 |
Est. completion date | September 1, 2027 |
Est. primary completion date | May 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 59 Months |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Direction Générale de l'Offre de Soins |
France,
Angoulvant 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. — View Citation
Angoulvant 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. — View Citation
Chang 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. — View Citation
Cohen 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. — View Citation
Gauzit 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. — View Citation
Ginsburg 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. — View Citation
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: a double-blind, randomized, placebo-controlled trial. Pediatr Infect Dis J. 2014 Feb;33(2):136-42. doi: 10.1097/INF.0000000000000023. — View Citation
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. — View Citation
Leekha 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. — View Citation
Pakistan 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. Erratum In: Lancet. 2003 Mar 1;361(9359):788. — View Citation
Same 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). |
Day 7 | |
Secondary | 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. |
Day 30 | |
Secondary | 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. |
Day 0, Day 3, Day 7 and Day 30 | |
Secondary | 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. |
Day 7, or Day 30 in case of therapeutic failure | |
Secondary | 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. |
Day 7 and Day 30 |
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