Group A Streptococcal PharyngitisPhase 4GASPARDNCT03264911
Group A Pharyngitis in Children: The GASPARD Study
A Phase 4 study of Group A Streptococcal Pharyngitis, run by Klara Posfay-Barbe at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Group A Streptococcal Pharyngitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Jan 2017to 31 Dec 2018
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3 -15 years old
- Clinical symptoms suggestive of pharyngitis with MC Isaac score ≥3
- Rapid-antigen detection test (RADT) positive for GAS-
- Signed informed parental/patient consent form
Who cannot join
- Hypersensitivity to B-lactams
- concomitant disease which must be treated with antibiotics
- chronic disease-Immunocompromised
- Antibiotics within 72 h
- history of ARF,scarlet fever,impetigo,acute glomerulonephritis
- Family history of ARF
- Complicated pharyngitis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Children's Hospital of Geneva (HUG)
Geneva, Canton of Geneva, 1211
Klara M Posfay-Barbe, MD, MS, +41 22 372 5462, Klara.PosfayBarbe@hcuge.ch
Klara M Posfay-Barbe, MD, MS
About this study
Official title: Group A Streptococcal Pharyngitis: Six Days Amoxicillin, oR Six Days Placebo in Children Between 3 and 15 Years Old:a Randomized, Double Blinded, Multicentred, Non-inferiority Trial
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.
Read the detailed description
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.
- Conditions
- Group A Streptococcal Pharyngitis
- Being tested
- Amoxicillin or Placebo
- Keywords
- pharyngitis, amoxicillin
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin or PlaceboDrug
Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Amoxicillin or Placebo |
| Placebo arm | Placebo comparator | Children will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days. Receives: Drug: Amoxicillin or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non inferiority
Duration of fever and other clinical signs/symptoms in not treated children versus treated
Measured: up to 1 month
Secondary outcomes (6)
Number of consultations for pharyngitis
To evaluate number of repeated consultations with pediatrician due to non-resolving/recurrent symptoms
Measured: 1 year
suppurative complications
to evaluate rates of suppurative complications (acute otitis media-sinusitis-quinsy-cellulitis-impetigo) of GAS infections
Measured: 1 year
non-suppurative complications
to evaluate rates of non-suppurative complications(ARF-glomerulonephritis-scarlet fever) of GAS infections
Measured: 1 year
eradication
to evaluate bacteriological eradication rates of the initial pathogen
Measured: 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
Measured: at inclusion
GAS strains
to investigate the biology and genetic structure of GAS strains in Switzerland.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start27 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Group A Streptococcal PharyngitisStudies 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
- prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klara Posfay-Barbe
- Sponsor type
- University, hospital or other
- Collaborators
- Gertrude Von Meissner Foundation, Recherche et Développement des HUG, Société académique de Genève
- Responsible party
- Sponsor-investigator, Klara Posfay-Barbe, University Hospital, Geneva
- Investigators
- Klara Posfay-Barbe, Principal investigator, Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264911
- Sponsor's protocol ID
- GASPARD
- Acronym
- GASPARD
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39215861
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group A Streptococcal Pharyngitis: Six Days Amoxicillin, oR Six Days Placebo in Children Between 3 and 15 Years Old:a Randomized, Double Blinded, Multicentred, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT03264911
- Acronym / sponsor ID
- GASPARD / GASPARD
- Conditions
- Group A Streptococcal Pharyngitis
- Keywords
- pharyngitis, amoxicillin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Klara Posfay-BarbeUniversity, hospital or other
- Collaborators
- Gertrude Von Meissner Foundation, Recherche et Développement des HUG, Société académique de Genève
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 29 Aug 2017 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, interventional, placebo-controlled, double-blinded, multicentric clinical trial
| Arm | Type | Receives |
|---|---|---|
| amoxicillin | Active comparator | Drug: Amoxicillin or PlaceboChildren 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 | Drug: Amoxicillin or PlaceboChildren will be randomized to receive, after consent to the study, a placebo orally, twice a day for 6 days. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 3 -15 years old
- Clinical symptoms suggestive of pharyngitis with MC Isaac score ≥3
- Rapid-antigen detection test (RADT) positive for GAS-
- Signed informed parental/patient consent form
Key exclusion criteria (7 listed)
- Hypersensitivity to B-lactams
- concomitant disease which must be treated with antibiotics
- chronic disease-Immunocompromised
- Antibiotics within 72 h
- history of ARF,scarlet fever,impetigo,acute glomerulonephritis
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 |
|---|---|---|
| Amoxicillin or PlaceboChildren will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment | Drug | Placebo arm, amoxicillin |
Primary outcome
Non inferiority
Time frame: up to 1 month
Duration of fever and other clinical signs/symptoms in not treated children versus treated
6 secondary outcomes
Number of consultations for pharyngitis
Time frame: 1 year
suppurative complications
Time frame: 1 year
non-suppurative complications
Time frame: 1 year
eradication
Time frame: 1 month
co-infections
Time frame: at inclusion
GAS strains
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Derived from this study: PubMed 39215861Gualtieri 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.
- Individual participant dataSharing planned: Undecided
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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.
Klara Posfay-Barbe principal investigator
Coordinator
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 of Group A Streptococcal Pharyngitis, run by Klara Posfay-Barbe at 1 site in Switzerland.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Aug 2017. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klara Posfay-Barbe (+4122372 5462, klara.posfaybarbe@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non inferiority (time frame: up to 1 month). 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 NCT03264911, which also lists 1 linked publication.
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 29 Aug 2017.