A Phase 4 interventional study of Amoxicillin or Placebo in Group A Streptococcal Pharyngitis, sponsored by Klara Posfay-Barbe. Status unknown at 1 site in Switzerland. Open to participants aged 3 Years to 15 Years. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Klara Posfay-Barbe · Phase 4, Interventional, and Treatment
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.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's planned enrollment of 360 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →This is the only study on the registry with Klara Posfay-Barbe as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Amoxicillin or Placebo
Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days.
Drug: Amoxicillin or Placebo
Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment
Non inferiority
Duration of fever and other clinical signs/symptoms in not treated children versus treated
Time frame: up to 1 month
Number of consultations for pharyngitis
To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms
Time frame: 1 year
suppurative complications
to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections
Time frame: 1 year
non-suppurative complications
to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections
Time frame: 1 year
eradication
to evaluate bacteriological eradication rates of the initial pathogen
Time frame: 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
Time frame: at inclusion
GAS strains
to investigate the biology and genetic structure of GAS strains in Switzerland.
Time frame: 1 month
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2017 (actual). Primary completion is estimated for Dec 2018, 23 months after the start.
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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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