Streptococcal Sore ThroatPhase 1NCT01310361
Once-daily Therapy for Streptococcal Pharyngitis
A Phase 1 study testing Amoxicillin and Intramuscular Benzathin Penicillin G in people with Streptococcal Sore Throat, run by Azad University of Medical Sciences at 1 site in Iran.
Trial summary
In some studies once daily amoxicillin therapy might be treatment of choice for Group A β-hemolytic Streptococcus pharyngitis in comparison with three to four times daily treatment with oral penicillin V. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Streptococcal Sore Throat
- What is being tested?
- Amoxicillin and Intramuscular Benzathin Penicillin G
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Jan 2004to Mar 2006
- Phase
- Phase 1
- 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 6 to 15 years
- All sexes
- Child
Who may be able to join
- Age of 6 to 15 years old.
- The criteria in clinical examination including objective signs (fever, Erythema or exudate of tonsils, enlarged lymph nodes) and subjective sign(sore throat). Neck tenderness, abdominal pain and pharynx petechia were also considered.
- No antibiotic was used during the week before.
- -Performing throat culture before the initiation of drug administration
- Positive throat culture indication GABHS
- No previous history of allergy to penicillin .
Who cannot join
- Age of below 6 years old or above 15 years old.
- No signs of pharyngitis in the clinical examination
- Antibiotic use during the week before.
- Throat culture was not performed before the initiation of drug administration.
- Negative throat culture or the culture indicates a microorganism other than GABHS.
- History of allergy to penicillin
- Not using drugs or not following the treatment in the field of having the second culture performed.
Trial locations and contacts
1 site in 1 country.
About this study
In some studies once daily amoxicillin therapy might be treatment of choice for Group A β-hemolytic Streptococcus pharyngitis in comparison with three to four times daily treatment with oral penicillin V.
- Conditions
- Streptococcal Sore Throat
- Being tested
- Amoxicillin, Intramuscular Benzathin Penicillin G
- Keywords
- Pharyngitis, Group A β-hemolytic Streptococci, Exudate, Erythema Penicillin, Amoxicillin
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Intramuscular Benzathin Penicillin GDrug
It is mentioned underlined in page 10 in research. (Once the throat swab was taken and cultured on plate at the place where the child was examined, hygiene teacher was trained about how to prepare the oral amoxicillin suspension and how to give it to the child. 750 milligrams of amoxicillin was thereafter given to the patient and in order not to infect other school children, the patient was sent home. The following morning, the patient would come to school and was given the second dose of amoxicillin by the hygiene teacher. All oral drugs were bought from a creditable company. In the injection group, 600000 units of penicillin was administered to children who weigh less than 27 kilograms and 1200000 units of penicillin was administered to children who weigh more. After 48 hours, patients were examined again when the result of first culture was ready)
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Experimental | Once-daily Therapy for Streptococcal Pharyngitis With Amoxicillin Receives: Drug: Amoxicillin |
| Benzathin Penicillin G | Active comparator | Once-daily Therapy for Streptococcal Pharyngitis With Intramuscular Benzathin Penicillin G Receives: Drug: Intramuscular Benzathin Penicillin G |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal Sore ThroatStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- Azad University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310361
- Sponsor's protocol ID
- iaum
- Status last verified
- Jan 2005
- First submitted
- 7 Mar 2011
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once-daily Therapy for Streptococcal Pharyngitis
- ClinicalTrials.gov ID
- NCT01310361
- Acronym / sponsor ID
- iaum
- Conditions
- Streptococcal Sore Throat
- Keywords
- Pharyngitis, Group A β-hemolytic Streptococci, Exudate, Erythema Penicillin, Amoxicillin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Azad University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Mar 2006
- First posted
- 8 Mar 2011 (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.
In some studies once daily amoxicillin therapy might be treatment of choice for Group A β-hemolytic Streptococcus pharyngitis in comparison with three to four times daily treatment with oral penicillin V.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Experimental | Drug: AmoxicillinOnce-daily Therapy for Streptococcal Pharyngitis With Amoxicillin |
| Benzathin Penicillin G | Active comparator | Drug: Intramuscular Benzathin Penicillin GOnce-daily Therapy for Streptococcal Pharyngitis With Intramuscular Benzathin Penicillin G |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age of 6 to 15 years old.
- The criteria in clinical examination including objective signs (fever, Erythema or exudate of tonsils, enlarged lymph nodes) and subjective sign(sore throat). Neck tenderness, abdominal pain and pharynx petechia were also considered.
- No antibiotic was used during the week before.
- -Performing throat culture before the initiation of drug administration
- Positive throat culture indication GABHS
Key exclusion criteria (7 listed)
- Age of below 6 years old or above 15 years old.
- No signs of pharyngitis in the clinical examination
- Antibiotic use during the week before.
- Throat culture was not performed before the initiation of drug administration.
- Negative throat culture or the culture indicates a microorganism other than GABHS.
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 | Drug | Amoxicillin |
| Intramuscular Benzathin Penicillin GIt is mentioned underlined in page 10 in research. (Once the throat swab was taken and cultured on plate at the place where the child was examined, hygiene teacher was trained about how to prepare the oral amoxicillin suspension and how to give it to the child. 750 milligrams of amoxicillin was thereafter given to the patient and in order not to infect other school children, the patient was sent home. The following morning, the patient would come to school and was given the second dose of amoxicillin by the hygiene teacher. All oral drugs were bought from a creditable company. In the injection group, 600000 units of penicillin was administered to children who weigh less than 27 kilograms and 1200000 units of penicillin was administered to children who weigh more. After 48 hours, patients were examined again when the result of first culture was ready) | Drug | Benzathin Penicillin G |
Primary outcome
Not reported in the source record.
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 8 Mar 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amoxicillin and Intramuscular Benzathin Penicillin G in people with Streptococcal Sore Throat, run by Azad University of Medical Sciences at 1 site in Iran.
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 6 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: finished, as of the sponsor's last update on 8 Mar 2011. 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 Iran. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 8 Mar 2011.