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CompletedNCT04215770Updated Jan 3, 2020

Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin

An interventional study of inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day in Tonsillitis Streptococcal, sponsored by Combined Military Hospital, Pakistan. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2020-01-03.

Sponsored by Combined Military Hospital, Pakistan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jan 2018, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
310
Allocation
Randomized
Ages
5 Years to 15 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tonsillitis Streptococcal

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Keywords

  • Co-amoxiclav
  • Benzyl Penicilli
  • Tonsillitis
03

In context

Tonsillitis

104 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.

This study's enrollment of 310 is above the median of 100 across 89 interventional studies indexed under Tonsillitis.

Browse Tonsillitis studies →

Lead sponsor

Combined Military Hospital, Pakistan is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Children who had 3 or 4 score according to Centor Criteria for tonsillitis/pharyngotonsillitis, were included in study
  2. Children between ages of 5 to 15 years
  3. Children with positive Rapid Antigen detection Test (RADT) for Streptococcus Pyogenes

Exclusion criteria

Exclusion Criteria:

  1. Immunocompromised children
  2. Children with known hypersensitivity to Penicillins (esp Coamoxiclav and Benzyl penicillin)
  3. Children with liver or renal failure
  4. Children who were already using any oral or parenteral antibiotics
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
310 participants (actual)

Study arms

  • Active comparator
    Inj Co-amoxiclav

    Group A children were advised Inj Co-amoxiclav 50 units/kg/day in 3 divided doses daily

    Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day

  • Active comparator
    Inj Benzyl Penicillin

    Group B patients were advised inj Benzyl Penicillin 25000 units/kg/day in 3 divided doses

    Drug: inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day

Interventions

  • Druginj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day

    Patients of both groups were examined and compared in terms of efficacy of treatment, safety and cost effectiveness

    Also known as: Group A and B

06

What researchers measure

Primary outcomes

  1. treatment efficacy

    full recovery (Centor score became zero/nil)

    Time frame: 10 days

07

Study locations

1 site
  • CMH Mradan
    Mardan, KPK, Pakistan
08

References and documents

Individual participant data

Plan to share: No — It will not be shared

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Nov 2019, 22 months.

Of 29 non-industry interventional studies with no phase under Tonsillitis, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 49. This study's 22 months is close to that.

Counting every sponsor, half of 29 studies reached it within 20 months; a quarter within 10 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 29, 2019
First posted
Jan 2, 2020
StartActual
Jan 1, 2018
Primary completionActual
Nov 1, 2019
CompletionActual
Nov 1, 2019
Last update
Jan 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04215770
Lead sponsor
Combined Military Hospital, Pakistan
Responsible party
Ahmed Khan (ENT consultant, Combined Military Hospital, Pakistan) — Principal investigator
First posted
Jan 2, 2020
Start date
Jan 1, 2018
Primary completion
Nov 1, 2019
Completion
Nov 1, 2019
Last update
Jan 3, 2020

Study contacts

Ahmed Khan, MBBS, FCPS
principal investigator · CMH Mardan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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