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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
| World Health Organization | OTHER |
| Cairo University | OTHER |
| University Hospital for Infectious Diseases, Croatia |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penicillin G, Benzathine | Drug | IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21-28 days after 1st visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark C. Steinhoff, MD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Rio de Janeiro | Rio de Janeiro | Brazil | ||||
| University Hospital for Infectious Diseases |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D000097902 | beta Lactam Antibiotics |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| OTHER |
| Universidade Federal do Rio de Janeiro | OTHER |
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| Amoxicillin | Drug | 750 mg/QD |
|
|
| 21-28 days after 1st visit |
| Zagreb |
| Croatia |
| Cairo University | Cairo | Egypt |
| D012141 | Respiratory Tract Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000900 | Anti-Bacterial Agents |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000667 | Ampicillin |