Tonsillitis StreptococcalNCT04215770
Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin
A study testing inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day in people with Tonsillitis Streptococcal, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
Trial summary
To compare intravenous Co-amoxiclav versus Benzyl penicillin in children with severe streptococcal tonsillitis in terms of efficacy, safety and cost effectiveness. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Tonsillitis Streptococcal
- What is being tested?
- inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2018to 1 Nov 2019
- Phase
- Interventional
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who had 3 or 4 score according to Centor Criteria for tonsillitis/pharyngotonsillitis, were included in study
- Children between ages of 5 to 15 years
- Children with positive Rapid Antigen detection Test (RADT) for Streptococcus Pyogenes
Who cannot join
- Immunocompromised children
- Children with known hypersensitivity to Penicillins (esp Coamoxiclav and Benzyl penicillin)
- Children with liver or renal failure
- Children who were already using any oral or parenteral antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin in Children With Severe Tonsillitis
To compare intravenous Co-amoxiclav versus Benzyl penicillin in children with severe streptococcal tonsillitis in terms of efficacy, safety and cost effectiveness.
Read the detailed description
Efficacy was measured through improvement (decrease in fever, settling lymphadenopathy and disappearance of tonsillar exudate) in Centor Criteria score on daily basis. Improvement i.e reduction in Centor Criteria score was recorded for all children till full recovery.
Safety was measured by frequency of hypersensitivity reactions or severe side effects of antibiotics necessitating stoppage of the drug. All the children in both Groups were given test dose of the antibiotic before giving full dose of antibiotic prescribed.
Cost effectiveness was compared in terms of total cost of injections (Co-amoxiclav versus Benzyl penicillin) which were administered to children in both groups.
- Conditions
- Tonsillitis Streptococcal
- Being tested
- inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day
- Keywords
- Co-amoxiclav, Benzyl Penicilli, Tonsillitis
- Medical subject headings
- Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/dayDrug
Also called Group A and B
Patients of both groups were examined and compared in terms of efficacy of treatment, safety and cost effectiveness
| Study group | Role | What they receive |
|---|---|---|
| Inj Co-amoxiclav | Active comparator | Group A children were advised Inj Co-amoxiclav 50 units/kg/day in 3 divided doses daily Receives: Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day |
| Inj Benzyl Penicillin | Active comparator | Group B patients were advised inj Benzyl Penicillin 25000 units/kg/day in 3 divided doses Receives: Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment efficacy
full recovery (Centor score became zero/nil)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Jan 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsillitis StreptococcalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blinded clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khan, Combined Military Hospital, Pakistan
- Investigators
- Ahmed Khan, MBBS, FCPS, Principal investigator, CMH Mardan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215770
- Sponsor's protocol ID
- CMH-01-2019
- Status last verified
- Dec 2019
- First submitted
- 29 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin in Children With Severe Tonsillitis
- ClinicalTrials.gov ID
- NCT04215770
- Acronym / sponsor ID
- CMH-01-2019
- Conditions
- Tonsillitis Streptococcal
- Keywords
- Co-amoxiclav, Benzyl Penicilli, Tonsillitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Combined Military Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 2 Jan 2020 (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.
To compare intravenous Co-amoxiclav versus Benzyl penicillin in children with severe streptococcal tonsillitis in terms of efficacy, safety and cost effectiveness.
Detailed description
Efficacy was measured through improvement (decrease in fever, settling lymphadenopathy and disappearance of tonsillar exudate) in Centor Criteria score on daily basis. Improvement i.e reduction in Centor Criteria score was recorded for all children till full recovery.
Safety was measured by frequency of hypersensitivity reactions or severe side effects of antibiotics necessitating stoppage of the drug. All the children in both Groups were given test dose of the antibiotic before giving full dose of antibiotic prescribed.
Cost effectiveness was compared in terms of total cost of injections (Co-amoxiclav versus Benzyl penicillin) which were administered to children in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| Inj Co-amoxiclav | Active comparator | Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/dayGroup A children were advised Inj Co-amoxiclav 50 units/kg/day in 3 divided doses daily |
| Inj Benzyl Penicillin | Active comparator | Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/dayGroup B patients were advised inj Benzyl Penicillin 25000 units/kg/day in 3 divided doses |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children who had 3 or 4 score according to Centor Criteria for tonsillitis/pharyngotonsillitis, were included in study
- Children between ages of 5 to 15 years
- Children with positive Rapid Antigen detection Test (RADT) for Streptococcus Pyogenes
Key exclusion criteria (4 listed)
- Immunocompromised children
- Children with known hypersensitivity to Penicillins (esp Coamoxiclav and Benzyl penicillin)
- Children with liver or renal failure
- Children who were already using any oral or parenteral antibiotics
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 |
|---|---|---|
| inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/dayAlso: Group A and BPatients of both groups were examined and compared in terms of efficacy of treatment, safety and cost effectiveness | Drug | Inj Benzyl Penicillin, Inj Co-amoxiclav |
Primary outcome
treatment efficacy
Time frame: 10 days
full recovery (Centor score became zero/nil)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: No. It will not be shared
Related trials for Tonsillitis Streptococcal
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Comparative Study of Adherence to Antibiotic Therapy Among Pediatric Patients: Hospital Emergency Department vs. Primary Care Center
Tonsillitis Acute, Pneumonia - Bacterial
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.
Ahmed Khan, MBBS, FCPS principal investigator
CMH Mardan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day in people with Tonsillitis Streptococcal, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 3 Jan 2020. 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 Pakistan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment efficacy (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2020.