Clinical trial: Intermittent Versus Continuous Infusion Meropenem in Cystic Fibrosis (NCT02048163)

Eligibility criteria:
Inclusion Criteria:

          1. Be an admitted patient at Dayton Children's Hospital.

          2. Between 7 and 21 years of age.

          3. Have a documented CF diagnosis with one or more of the following clinical features:

               1. Sweat chloride > 60 mEq/liter as determined by quantitative pilocarpine
                  iontophoresis test (QPIT).

               2. Two mutations (well characterized) in the cystic fibrosis transmembrane
                  conductive regulator (CTFR) gene.

               3. Abnormal nasal potential difference.

          4. Based on Hankinson/NHanes III criteria, are able to elicit an FEV1 > 25% but with <
             95% predicted value when admitted.

          5. Sputum or throat swab specimen positive for P. aeruginosa and have a history of at
             least one additional sputum culture positive for P. aeruginosa within the last 12
             months.

          6. Are able to perform an acceptable spirometry session (defined as 3 acceptable or
             usable efforts per ATS/ERS criteria upon admission).

          7. Have not smoked tobacco within 28 days prior to Visit 1 and agree not to smoke for the
             duration of the study.

          8. Are able to and have given written informed consent (if they are adults) or assent in
             combination with consent of their legal representative(s) (if they are minors) in a
             manner approved by the Institutional Review Board.

          9. Patient is experiencing symptoms of CF exacerbation of CF: with any 4 of the following
             12 signs or symptoms:

               -  Change in sputum;

               -  New or increased hemoptysis;

               -  Increased cough;

               -  Increased dyspnea;

               -  Malaise, fatigue or lethargy;

               -  Temperature above 38°C;

               -  Anorexia or weight loss;

               -  Sinus pain or tenderness;

               -  Change in sinus discharge;

               -  Change in physical examination of the chest;

               -  Decrease in pulmonary function by 10 percent or more from a previously recorded
                  value;

               -  Radiographic changes indicative of pulmonary infection.

        Exclusion Criteria:

          1. History of hypersensitivity or intolerance to meropenem.

          2. History of hypersensitivity or intolerance to granisetron.

          3. Are pregnant, breastfeeding, or unwilling to practice a highly effective method of
             birth control or abstinence during participation in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 21 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction