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| Name | Class |
|---|---|
| Gertrude Von Meissner Foundation | OTHER |
| Recherche et Développement des HUG | UNKNOWN |
| Société académique de Genève | UNKNOWN |
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Evaluate the necessity to treat with antibiotics GAS pharyngitis in children in Switzerland. The null hypothesis is that antibiotic treatment is not necessary for GAS pharyngitis in this population.
All children between 3 -15 years old with clinical symptoms suggestive of pharyngitis (Mc Isaac score ≥3) and a microbiological test (rapid antigen detection) positive for group A Streptococcus (GAS) will be included in the study. In order to assess the strain of GAS as well as to identify co-infected children with respiratory virus, a throat culture and a nasopharyngeal swab will be performed, as well as a standard questionnaire and a standard physical exam. At this time, children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment. During the treatment period, the investigators will ask the parents/legal guardians of the patients to pay close attention to the evolution of the symptoms (fever, pain, exudates…) as well as the treatment's adverse event, and to report their presence or absence in a dairy form. At day three after initiation of treatment, a standardized clinical evaluation will be completed by phone to identify if the patient still has symptoms of pharyngitis or signs of suppurative complications. One month after the inclusion in the study, a throat culture, a standardized questionnaire as well as a clinical evaluation will be performed to identify if the patient has or had signs of non-suppurative complications and non-resolving infection. Six month and one year after inclusion, a phone call will evaluate the possible relapses, recurrences and complications of GAS infection with a standardized questionnaire. GAS strains will be analyzed to identify their unique fingerprint and viral coinfections will be reported to possibly identify cofactors for increased complication rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amoxicillin | Active Comparator | Children will be randomized to receive, after consent to the study, an antibiotic (amoxicillin approximately 50 mg/kg/day) orally, twice a day for 6 days. |
|
| Placebo arm | Placebo Comparator | Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin or Placebo | Drug | Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non inferiority | Duration of fever and other clinical signs/symptoms in not treated children versus treated | up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of consultations for pharyngitis | To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms | 1 year |
| suppurative complications | to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klara Posfay-Barbe | Contact | +4122372 5462 | klara.posfaybarbe@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| Klara Posfay-Barbe | Coordinator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Geneva (HUG) | Recruiting | Geneva | Canton of Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39215861 | Derived | Gualtieri R, Verolet C, Mardegan C, Papis S, Loevy N, Asner S, Rohr M, Llor J, Heininger U, Lacroix L, Pittet LF, Posfay-Barbe KM. Amoxicillin vs. placebo to reduce symptoms in children with group A streptococcal pharyngitis: a randomized, multicenter, double-blind, non-inferiority trial. Eur J Pediatr. 2024 Nov;183(11):4773-4782. doi: 10.1007/s00431-024-05705-1. Epub 2024 Aug 31. |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial
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| 1 year |
| non-suppurative complications | to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections | 1 year |
| eradication | to evaluate bacteriological eradication rates of the initial pathogen | 1 month |
| co-infections | to discover if respiratory viruses are detected as co-infections in children with GAS pharyngitis upon initial presentation and during a recurrent episode | at inclusion |
| GAS strains | to investigate the biology and genetic structure of GAS strains in Switzerland. | 1 month |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |