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We were not able to secure IRB approval in the timeline necessary to do this study.
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Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond targeted PCR testing to next generation sequencing techniques. In addition, the current state of monitoring for soil-transmitted helminth infections is moving increasingly from microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool samples are logistically challenging and time-intensive to collect, thus participation is often far from optimal. Rectal swabs are more efficient and may result in higher participation. In this study, children will be randomized to either albendazole, azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be collected. The investigators will compare the PCR test for soil transmitted helminth infections using both the rectal swabs and the bulk stool samples. In addition, the investigators will analyze the gut microbiome of the children using next generation sequencing techniques to gain insight into effects of mass drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albendazole at day 0, azithromycin at day 7 | Experimental |
| |
| azithromycin at day 0, albendazole at day 7 | Experimental |
| |
| albendazole at day 0, azithromycin at day 0 | Experimental |
| |
| Delayed treatment | Other | albendazole at day 7, azithromycin at day 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug |
| ||
| Albendazole |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial diversity in the intestinal microbiomes of children aged 1-60 months | Microbiota diversity in the intestinal microbiomes of children aged 1-60 months in azithromycin-treated, albendazole-treated, azithromycin+albendazole-treated and delayed treatment arms using phylogenetic distance measures | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5 | The investigators use PCR to identify soil transmitted helming infections in rectal swab samples and bulk stool sample from the same child. Using the bulk stool sample as the gold standard, the investigators will calculate the sensitivity, specificity, PPV, and NPV of the rectal swabs for detecting the various helminth infections. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Keenan, MD, MPH | F.I. Proctor Foundation, University of California San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Carter Center Ethiopia | Addis Ababa | Ethiopia |
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| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| ID | Term |
|---|---|
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D015766 | Albendazole |
| D000096182 | Treatment Delay |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Drug |
|
| Delayed treatment | Drug | Albendazole+Azithromycin |
|
| Day 7 |
| Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061665 | Time-to-Treatment |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |