Transmission and the Respiratory Tract in Cryptosporidiosis (NCT00507871) | Clinical Trial Compass
CompletedNot Applicable
Transmission and the Respiratory Tract in Cryptosporidiosis
Uganda480 participantsStarted 2007-10
Plain-language summary
Cryptosporidium is an intestinal parasite that causes diarrhea in children and adults. In addition to infection of the stomach, this parasite can infect the respiratory system causing a cough and/or problems breathing. This study will enroll 480 children between the ages of 9 and 36 months who come to Mulago Hospital for treatment of diarrhea. Researchers believe a large number of children with diarrhea and cough will have the parasite present in their sputum (mucus coughed up). Researchers also believe that children who have respiratory tract cryptosporidiosis may have a cough, increased number of breaths per minute, and/or a lower oxygen level. Blood, stool, saliva, and sputum samples will be collected from all children in the study and tested for Cryptosporidium. Children too young to provide a sputum sample will have a tube placed to collect a mucus sample from the lungs. Study participation may be as short as 4 hours or as long as 2 days depending on each child's health.
Who can participate
Age range
9 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female children aged 9-36 months at the time of enrollment
* Presence of acute or persistent diarrhea (diarrhea defined as 3 or more loose stool in the previous 24 hours AND not considered normal for that child if the child is exclusively breast fed OR any number of bloody stools in the previous 24 hours; less than or equal to 14 days duration for acute diarrhea; \>14 days duration for persistent diarrhea)
* Child's parent/guardian speaks English or Luganda
* Parent/guardian provides full and free informed consent for child to participate in study
Exclusion Criteria:
* Unknown age
* Known cardiac, CNS, metabolic or endocrine disorders
* Moribund children
* Children with recent history of choking or sudden onset of symptoms with suspected foreign body inhalation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.