Streptococcal InfectionsTOPSNCT01156740
Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings
A study testing Penicillin G, Benzathine and Amoxicillin in people with Streptococcal Infections and Pharyngitis, run by Johns Hopkins University at 3 sites in 3 countries.
Trial summary
The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Streptococcal Infections, Pharyngitis
- What is being tested?
- Penicillin G, Benzathine and Amoxicillin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2001to Apr 2003
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2-12 years old,
- Presenting with complaint of sore throat
- Parental consent given and child assent if 5 years or older
Who cannot join
- The parent/guardian reported oral antibiotic use in the past 3 days or injectable penicillin in past 28 days prior to screening
- Had a history of rheumatic fever or rheumatic heart disease
- Required hospitalization for any reason at the time of enrollment
- Had previously been enrolled in the study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Treatment of Pharyngitis Study (TOPS): A Randomized Equivalence Trial of Intramuscular Penicillin G vs. Oral Amoxicillin Antibiotics for the Treatment of Streptococcal Pharyngitis in Children in Developing Countries
The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
- Conditions
- Streptococcal Infections, Pharyngitis
- Being tested
- Penicillin G, Benzathine, Amoxicillin
- Keywords
- streptococcal pharyngitis, randomized clinical trial, amoxicillin, intramuscular benzathine penicillin G.
- Medical subject headings
- Streptococcal Infections, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penicillin G, BenzathineDrug
Also called Intramuscular Benzathine Penicillin G, Beta-lactam antibiotics
IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg)
AmoxicillinDrug
Also called Amoxil®, Trimox®
750 mg/QD
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular benzathine Penicillin G | Active comparator | A single dose of intramuscularly administered intramuscular benzathine penicillin G (IM BPG). The dosing was as follows: IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg Receives: Drug: Penicillin G, Benzathine |
| Amoxicillin | Active comparator | A 10-day once daily dose of Amoxicillin was given in an oral form. The first dose was given at the time of randomization, and parents were instructed on giving the remaining doses. Dosing was as follows: 750 mg/QD Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of Group A Streptococcus (GAS)
The primary outcome of the study was bacteriologic treatment success, which was defined as eradication of GAS from the pharynx at the follow up visit. Eradication was defined as no GAS present on the throat culture.
Measured: 21-28 days after 1st visit
Secondary outcomes (1)
Compliance to treatment
Compliance with the amoxicillin treatment regimen was assessed at the follow up visit. The primary measure of compliance was the presence of antimicrobial activity in the urine-impregnated filter paper strips. For those who did not return the filter paper strip, compliance was measured by parent/guardian report during the exit interview. Patients who did not fulfill at least one of these criteria were considered noncompliant.
Measured: 21-28 days after 1st visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startAug 2001
- Primary completionApr 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), World Health Organization, Cairo University, University Hospital for Infectious Diseases, Croatia, Universidade Federal do Rio de Janeiro
- Investigators
- Mark C. Steinhoff, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156740
- Sponsor's protocol ID
- HRN-A-00-96-90006-00
- Acronym
- TOPS
- Status last verified
- Dec 2009
- First submitted
- 2 Jul 2010
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pharyngitis Study (TOPS): A Randomized Equivalence Trial of Intramuscular Penicillin G vs. Oral Amoxicillin Antibiotics for the Treatment of Streptococcal Pharyngitis in Children in Developing Countries
- ClinicalTrials.gov ID
- NCT01156740
- Acronym / sponsor ID
- TOPS / HRN-A-00-96-90006-00
- Conditions
- Streptococcal Infections, Pharyngitis
- Keywords
- streptococcal pharyngitis, randomized clinical trial, amoxicillin, intramuscular benzathine penicillin G.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), World Health Organization, Cairo University, University Hospital for Infectious Diseases, Croatia, Universidade Federal do Rio de Janeiro
- Study start
- Aug 2001
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 5 Jul 2010 (estimated)
- 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.
The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular benzathine Penicillin G | Active comparator | Drug: Penicillin G, BenzathineA single dose of intramuscularly administered intramuscular benzathine penicillin G (IM BPG). The dosing was as follows: IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg |
| Amoxicillin | Active comparator | Drug: AmoxicillinA 10-day once daily dose of Amoxicillin was given in an oral form. The first dose was given at the time of randomization, and parents were instructed on giving the remaining doses. Dosing was as follows: 750 mg/QD |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 2-12 years old,
- Presenting with complaint of sore throat
- Parental consent given and child assent if 5 years or older
Key exclusion criteria (4 listed)
- The parent/guardian reported oral antibiotic use in the past 3 days or injectable penicillin in past 28 days prior to screening
- Had a history of rheumatic fever or rheumatic heart disease
- Required hospitalization for any reason at the time of enrollment
- Had previously been enrolled in the study
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 |
|---|---|---|
| Penicillin G, BenzathineAlso: Intramuscular Benzathine Penicillin G, Beta-lactam antibioticsIM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg) | Drug | Intramuscular benzathine Penicillin G |
| AmoxicillinAlso: Amoxil®, Trimox®750 mg/QD | Drug | Amoxicillin |
Primary outcome
Eradication of Group A Streptococcus (GAS)
Time frame: 21-28 days after 1st visit
The primary outcome of the study was bacteriologic treatment success, which was defined as eradication of GAS from the pharynx at the follow up visit. Eradication was defined as no GAS present on the throat culture.
1 secondary outcome
Compliance to treatment
Time frame: 21-28 days after 1st visit
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 5 Jul 2010.
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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.
Mark C. Steinhoff, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penicillin G, Benzathine and Amoxicillin in people with Streptococcal Infections and Pharyngitis, run by Johns Hopkins University at 3 sites in 3 countries.
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 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Croatia, Egypt. 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?
Eradication of Group A Streptococcus (GAS) (time frame: 21-28 days after 1st visit). 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 5 Jul 2010; AzTrials last refreshed its copy on 8 Nov 2026.