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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
| Health Oriented Preventive Education | OTHER |
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The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bismuth subsalicylate | Experimental | Bismuth subsalicylate, 262 mg/chewable tablet, 2 tablets every hour as needed up to 16 tablets per 24 hours, for up to 48 hours. |
|
| Placebo | Placebo Comparator | Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bismuth subsalicylate | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| use of antimicrobial medications | within 5 days of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's perceived need for antibiotics | Within 48 h of enrollment | |
| additional care obtained for diarrhea | Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Bowen, MD, MPH | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPE | Karachi | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31418805 | Derived | Bowen A, Agboatwalla M, Pitz A, Salahuddin S, Brum J, Plikaytis B. Effect of Bismuth Subsalicylate vs Placebo on Use of Antibiotics Among Adult Outpatients With Diarrhea in Pakistan: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199441. doi: 10.1001/jamanetworkopen.2019.9441. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C015715 | bismuth subsalicylate |
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| Other |
Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate |
|
| within 48 h of enrollment |
| Additional care obtained for diarrheal illness | Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness | within 5 days of enrollment |
| Disease severity and duration | Time to first formed stool Number of stools during first 48 h of observation Duration of abdominal pain Duration of nausea Time to resolution of illness (any of the following symptoms: diarrhea, nausea, vomiting, abdominal pain) Severity of all symptoms of illness | within 5 days of enrollment |
| Patient experience with the study drug | i. Satisfaction with resolution of symptoms ii. Satisfaction with esthetics of study medication iii. Adverse effects | within 5 days of enrollment |
| D004066 | Digestive System Diseases |