Homeostec for the treatment of chronic Chikungunya

• Register: RPCEC
• Last refreshed on: 1 April 2024
• Main ID: RPCEC00000226
• Date of registration: 27/12/2016
• Prospective Registration: Yes
• Primary sponsor: Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
• Public title: Homeostec for the treatment of chronic Chikungunya
• Scientific title: Toxicity of the intravenous application of Homeostec in patients with chronic manifestations of Chikungunya virus infection: Clinical Trial Phase I. - CHIKCRONTX
• Date of first enrolment: 10/01/2017
• Target sample size: 20
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000226-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Other. Purpose: Treatment
• Phase: 1

Countries of recruitment

Mexico

Contacts

• Name: Ivan Delgado Enciso
• Affiliation: Cancerology State Institute, Colima State Health Service

• Name: Ivan Delgado Enciso
• Affiliation: Cancerology State Institute, Colima State Health Service

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with confirmed diagnosis of Chikungunya virus infection by RT-PCR or ELISA (IgG and / or IgM anti-Chikungunya) in the previous months.
2. Age: 18 years and older.
3. Persistent musculoskeletal pain or arthritis for more than 4 weeks after onset of Chikungunya virus infection.
4. Suffering musculoskeletal or joint pain maximum on analogue-visual scale of 4 or more in the last 24 hours
5. Acceptance in writing, previous information.
6. Negative urine pregnancy test.
Exclusion criteria: 1. Rheumatoid arthritis.
2. Autoimmune diseases.
3. Symptomatic osteoarthritis prior to infection.
4. Decompensated systemic disease.
5. Creatinine 1.25 times greater than normal value or creatinine clearance less than 50 milliliters / minute (Cockfrot and Gault method). 6. Leukocytes equal to or less than 3000 cells / µL or platelet count less than 100,000 cells / µl.
7. Blood hemoglobin less than 10g / dL.
8. Increase in the last month of diastolic blood pressure to 110 mmHg or more and / or appearance of hematuria or proteinuria greater than 300 milligrams / day.
9. Pseudo intestinal obstruction. Defined as abdominal pain, with airway levels on AP and lateral lateral views of the abdomen.
10. Pregnant women or women of childbearing potential without a contraceptive method: salpingoclasia, device or hormonal, or Breastfeeding women.
11. Alcoholism and/or drug addiction.
12. Known liver disease with twice the increase in liver function tests (Aspartate amino transferase (AST), Alaninoamino transferase (ALT), alkaline phosphatase, bilirubin).
13. Presence of: Cancer.
14. Other pathologies at the discretion of the researcher.

Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Infection

Chikungunya Fever

Chronic Joint Disease Caused by Chikungunya Virus

Arthritis, Infectious

Musculoskeletal Diseases

Arthritis

Joint Diseases

Intervention(s)

Infusions, Intravenous

Solutions

Administration, Intravenous

Administration, Oral

Group I (experimental): Homeostec (5 ml) + Paracetamol (500 mg). The patient will receive 5 ml de Homeostec intravenously (electrolyzed solution with neutro ph) diluted in 20 ml of salt solution (NaCl) al 0.9%, in slow infusion, to pass in 10 minutes. The patient will be monitored, in hospital bed for 6 hours. If the patient has no adverse effects, the procedure will be repeated at 24 and 48 hours. Also, the patients can take Paracetamol 500mg by oral route every 8 hours in case of pain for their illness.
Group II (experimental): Homeostec (10 ml) + Paracetamol (500 mg)). The patient will receive 10 ml de Homeostec intravenously (electrolyzed solution with neutro ph) diluted in 40 ml of salt solution (NaCl) al 0.9%, in slow infusion, to pass in 10 minutes. The patient will be monitored, in hospital bed for 6 hours. If the patient has no adverse effects, the procedure will be repeated at 24 and 48 hours. Also, the patients can take Paracetamol 500mg by oral route every 8 hours in case of pain for their illness.
Group III (experimental): Homeostec (20 ml) + Paracetamol (500 mg)). The patient will receive 20 ml de Homeostec intravenously (electrolyzed solution with neutro ph) diluted in 80 ml of salt solution (NaCl) al 0.9%, in slow infusion, to pass in 10 minutes. The patient will be monitored, in hospital bed for 6 hours. If the patient has no adverse effects, the procedure will be repeated at 24 and 48 hours. Also, the patients can take Paracetamol 500mg by oral route every 8 hours in case of pain for their illness.
Group IV (Control): Paracetamol (500 mg). The patients will receive 500mg of Paracetamol every 8 hours by oral route if they have pain and, they will be managed by your family physician.

Homeostec,
Solución electrolizada,
Paracetamol

Acetaminophen

Tablets

Primary Outcome(s)

Adverse Events (Present, Absent. Adverse Events will be measured according to the Common Terminology Criteria for Adverse Events V3.0 (CTCAE). During the application of HOMEOSTEC the patient will have a cardiac monitor during 6 hours. Blood tests (pH, blood count, serum electrolytes, bleeding tests, and blood chemistry), physical examination and interrogation will be performed). Measuring time: at baseline, at 15 and 60 minutes, at 6, 24, 48 and 72 hours, at 15 and 30 days.

Secondary Outcome(s)

Joint pain (analogue-numeric scale of pain). Measuring time: at baseline, at 6, 24, 48 and 72 hours, at 15 and 30 days.
Progression of joint disease (Routine Assessment of Patient Index Data-RAPID 3, >12 = High; between 6.1 and 12 Moderate; between 3.1 and 6 low; between 0 and 3 remission): Measuring time: at baseline, at 6, 24, 48 and 72 hours, at 15 and 30 days.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Colima State Health Service (SSA-COLIMA), Mexico ESTERIPHARMA Foundation for Ethics, Education and Research for the Cancer of the Cancerology State Institute A.C.

Secondary Sponsor(s)

ESTERIPHARMA