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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT02083068
Eligibility Criteria:
Inclusion Criteria:
* Naïve group
Healthy men and women aged 18-45 years. Signing freely and voluntary informed consent , accompanied by two witnesses who also sign.
Not have a history of malaria infection. For women, use of adequate contraception from the star restriction to be lifted by a doctor for contraception study. Accept not to travel to areas considered endemic for malaria during Trophies infectious period (1 month ) ( Buenaventura , Tierralta , Pretoria , Tumaco ,Urabá and Bajo Cauca) .
Be reachable by phone throughout the study period. Being Duffy positive ( Fy +) . Levels of hemoglobin ( Hb) \> 11 g / dl. Availability to participate during the period in which they develop the study. Do not be participating in another clinical study
2\. Preimmune group
Healthy men and women aged 18-45 years. Signing freely and voluntary informed consent , accompanied by two witnesses who also sign .
Having a history of infection (s ) and serological tests for malaria positive for P. vivax.
For women, use adequate contraception from the start restriction to be lifted by a doctor for contraception study .
Accept not to travel to areas considered endemic for malaria during Trophies infectious period (1 month ) ( Buenaventura , Tierralta , Pretoria , Tumaco Urabá and Bajo Cauca) .
Be reachable by phone throughout the study period. Availability to participate during the period in which they develop the study.
3\. Voluntary blood donors
* Healthy men and women aged 18-45 years.
* Be positive diagnosis of P. vivax determined by thick smear examination .
* The patient must not have circulating malaria parasites such as P. falciparum or P. malariae .
* Have a parasitemia ≥ 0.1 %. by thick smear .
* Hb ≥ 9 g / dL at the time of diagnosis of malaria.
* The patient must have the capacity to provide informed consent freely and voluntarily . Should be illiterate may assert its decision to participate by putting their fingerprint in the format consent. Minors who are between 15 and 17 and wishing to participate must sign the informed consent and one of its Parents must sign the informed consent, accompanied by 2 witnesses who also sign
Exclusion Criteria:
* Step 1
* Negative IFAT (\< 1:20) for P. vivax on screening tests
* Other criteria used in the case of naive volunteers, except a history of having lived in an endemic area for the past 6 months.
Step 2 Patients that have chronic or acute disease, different from malaria by P. vivax.
Having a history of disease or clinical conditions that according to medical criteria might increase significantly the risk related with participation on this study Hemoglobin levels \<9 g/dL at the time of recruitment Have received antimalarial treatment before the diagnosis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02083068
Study Brief:
Protocol Section:
NCT02083068