Background
Rationale
Study objectives
Primary objectives
Secondary objectives
Primary outcomes
Secondary outcomes
Methods/design
Study type
Study location
Study population
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Male or female
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Age 2–24 months
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Hospitalized with diarrhea (defined as 3 or more loose stools within 24 h)
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Lives within 15 km radius of Blantyre district
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Positive on sputum/NP swab or stool for Cryptosporidium by PCR
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Parent/guardian consent for enrollment
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Dysentery (visible blood in loose stool)
Study procedures
Recruitment
Screening
Sampling procedures
Enrollment and follow-up
Visit | Activities |
---|---|
1 | Admission to the inpatient ward, assessment, collection of induced sputum and stool sample |
1a. If sputum/NP/stool is positive for Cryptosporidium, continue to follow | |
1b. If sputum/NP/stool is negative for Cryptosporidium, discontinue from study | |
If the patient remains hospitalized for longer than 2 weeks then sputum/NP swab and stool samples will be collected fortnightly until discharge. | |
2 | Outpatient Week 2 follow-up visit, assessment, collection of induced sputum/NP swab and stool sample |
3 | Outpatient Week 4 follow-up visit, assessment, collection of induced sputum/NP swab and stool sample |
4 | Outpatient Week 6 follow-up visit, assessment, collection of induced sputum/NP swab and stool sample |
5 | Outpatient Week 8 follow-up visit, assessment, collection of induced sputum/NP swab and stool sample |
Study event | Study day/Interval | ||||||
---|---|---|---|---|---|---|---|
Inpatient | Outpatient visits (Week post-discharge) | ||||||
Admission | Every 2 weeks | Discharge | 2 | 4 | 6 | 8 | |
Informed consent | X | ||||||
Inclusion/exclusion criteria | X | ||||||
Demographics | X | ||||||
Medical history | X | X | X | X | X | X | X |
Vital signs | X | X | X | X | X | X | X |
Physical exam | X | X | X | X | X | X | X |
HIV rapid test +/− HIV DNA PCRa | X | ||||||
Relevant investigations (e.g. CXR, FBC, blood culture, etc.) | +/− Only if clinically indicated | ||||||
Induced sputum for microscopy, Cryptosporidium qPCR, and multiplex testing | X | X | Xb | Xb | Xb | Xb | |
NP swab for Cryptosporidium qPCR for first 100 subjects only | X | X | Xb | Xb | Xb | Xb | |
Stool for TaqMan array | X | X | Xb | Xb | Xb | Xb |
Laboratory processing
HIV testing
Induced sputum and stool processing
Statistical analysis
Sample size
Analysis
Proportion of children with Crypto diarrhea (%) | Number of children with Crypto diarrhea | Proportion of children hospitalized with Cryptosporidium diarrhea with a positive sputum test (%) | |||||||
---|---|---|---|---|---|---|---|---|---|
15 | 20 | 25 | 30 | 35 | 40 | 45 | 50 | ||
10 | 25 | 15.77 | 16.94 | 17.89 | 19.28 | 19.75 | 20.10 | 20.33 | 20.45 |
12 | 30 | 13.48 | 15.43 | 16.80 | 17.33 | 17.76 | 18.37 | 18.67 | 18.70 |
14 | 35 | 12.73 | 14.25 | 15.38 | 16.22 | 16.54 | 17.01 | 17.26 | 17.31 |
16 | 40 | 12.06 | 13.30 | 14.25 | 14.98 | 15.53 | 15.90 | 16.13 | 16.20 |