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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI167788-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months. The main questions it aims to answer are:
Researchers will compare NTZ to a placebo (a look-alike substance that contains no drug) to see if NTZ works to treat Cryptosporidium.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitazoxanide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide | Drug | 5 mL suspension (100 mg), 2x/day for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Days of Cryptosporidium-associated diarrhea | 7 days | |
| Time to clearance of Cryptosporidium from stool | Measured in days | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, total and stratified by age | 6 months | |
| Time-to-first Cryptosporidium infection in sibling | Measured in days | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Poonum S Korpe, MD | Contact | 7037254821 | pkorpe1@jhu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Poonum Korpe, MD | Johns Hopkins University | Principal Investigator |
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| ID | Term |
|---|---|
| D003457 | Cryptosporidiosis |
| ID | Term |
|---|---|
| D007411 | Intestinal Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D011529 | Protozoan Infections, Animal |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
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| Placebo |
| Drug |
identical in consistency, appearance, and taste to nitazoxanide suspension. 5 mL suspension given 2x/day for 3 days |
|
| Change in weight from baseline to 6 months post-treatment |
Weight measured in kilograms |
| Baseline, 6 months |
| Change in Lactulose:Mannitol ratio from baseline to 6 months post treatment | Baseline, 6 months |
| Change in height-for-age adjusted z-score from baseline to 6 months post treatment | Measured in centimeters | Baseline, 6 months |
| D010273 | Parasitic Diseases, Animal |
| D003048 | Coccidiosis |
| D011528 | Protozoan Infections |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D000820 | Animal Diseases |