Objectives, Impact and Work Packages for CryptoT&T

Primary objective

Estimate the effectiveness of a low-cost point-of-care test followed by targeted cryptosporidiosis treatment with nitazoxanide on diarrheal duration in children presenting to health care facilities with diarrhoea.

Secondary objectives

1. To validate the sensitivity, specificity, positive and negative predictive values (PPV and NPV), of LED-AP cryptosporidiosis POC-testing scaled-up real-life clinical settings, compared with quantitative PCR as a reference test
2. To assess sensitivity, specificity, PPV and NPV, and reduction in total test TAT of using rectal swab specimens instead of bulk stool samples
3. To assess the cost-effectiveness of an LED-AP based test-and-treat strategy against cryptosporidiosis
4. To explore differences in mortality and growth parameters 60 days after enrolment in children in the intervention arm with LED-AP based testing-and-treatment compared with children in the control arm
5. To explore the effectiveness of an LED-AP-based test-and-treat strategy in vulnerable groups such as children with acute malnutrition or prolonged or persistent diarrhoea

• WP1 Coordination and project management
• WP2 Scientific project leadership
• WP3 Diagnostic stepped-wedge cluster randomised trial
• WP4 Improving total test turnaround time with rectal swabs for cryptosporidiosis testing
• WP5 Capacity building
• WP6 Data management and analysis
• WP7 Cost-effectiveness analysis
• WP8 Technology development and grassroot innovation
• WP9 Dissemination, Exploitation and Communication

This project aligns with the UN Sustainable Development Goal 3 and WHO initiatives to reduce the burden of diarrheal diseases. Effective POC diagnostics and treatment are expected to alleviate diarrhea and reduce long-term complications. The introduction of cryptosporidiosis testing can enhance surveillance of this critical pathogen.

Outcomes will be of significant interest to health facility staff, ministries of health in SSA, WHO, and the scientific community. This study will provide crucial data on optimizing LED-AP testing to guide clinical decision-making and targeted treatment, thereby preventing the overuse of antibiotics. The findings can be helpful in updating current diarrheal treatment guidelines, which primarily advocate for syndromic treatment.