Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT01328457
Eligibility Criteria:
Inclusion Criteria:
1. Signs and symptoms of VL including:
* History of intermittent fever for at least two weeks
* History of weight loss and/or decrease in appetite
* Enlarged spleen
2. VL serologically confirmed using the rK39 test:
3. Willingness / ability to understand and provide informed consent prior to participation in this study:
4. Age ≥ five years and ≤ 55 years, and weighing at least five kg
5. Adequately hydrated as assessed by clinical criteria and able to maintain adequate hydration on an outpatient basis through oral intake of fluids
6. Clinically stable and appropriate for treatment with PMIM as an outpatient, if possible (subjects may be hospitalized to receive 21-day dosing at the discretion of the investigator)
7. Living in the VL-endemic areas in Bangladesh
Exclusion Criteria:
1. Active tuberculosis or taking anti-tuberculosis medications
2. Previous treatment with Paromomycin IM Injection (PMIM)
3. Clinically significant severe anemia as determined by the investigator
4. Clinically significant renal or hepatic dysfunction as determined by the investigator, or history of clinically significant renal or hepatic dysfunction
5. History of Hepatitis B or C; or known HIV positive
6. History of hearing loss
7. Other serious illness or medical condition that, in the opinion of the doctor, would interfere with the patient's ability to receive PMIM treatment or comply with the study procedures, or that could obscure toxicity of or response to PMIM
8. Major surgery within 30 days prior to first dose of PMIM
9. History of hypersensitivity to aminoglycosides or to any of the components of PMIM, including sulfite
10. Any history of VL or treatment of VL at any time
11. Patients who have received any investigational (unlicensed) drug within the last six months
12. Concomitant use of other aminoglycosides (e.g., gentamicin, tobramycin, amikacin), nephrotoxic and ototoxic drugs, or immunosuppressive drugs
13. Proteinuria (results \> 1+ ) on urine dipstick analysis at screening visit and/or
14. Serum creatinine above the upper limit of normal (ie, serum creatinine \>1.1 mg/dl in males and \>0.9 mg/dl in females
15. Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
55 Years
Study:
NCT01328457
Study Brief:
Protocol Section:
NCT01328457