SYNRIAM tablets in Malaria

Phase 4

Completed

• Conditions: Health Condition 1: null- Acute Uncomplicated Plasmodium vivax MalariaHealth Condition 2: I998- Other disorder of circulatory system

• Registration Number: CTRI/2015/07/006050
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1.Age greater or equal 12 years, both male and female, who have given written informed assent/consent for audio visual recording of consent procedure and written informed assent/consent to participate in the study. An additional written informed consent will be obtained from parent/legally acceptable representative (as applicable) in case assent is taken from subjects aged less than 18 years.

2.Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by positive blood smear with asexual forms of P. vivax parasites only.

3.Parasite density appropriate for inclusion will be greater than 250/micro L of blood

4.Presence of fever (axillary temperature greater or equal to 37.5 deg C or oral greater or equal to 38 deg C) or a history of fever in the past 48 hours.

5.Willingness and ability to comply with the study protocol for the duration of the study.

6.Residence within a reasonable distance of the investigational site, so that attendance of all study visits and follow-up by medical staff are logistically feasible.

Exclusion Criteria

1.Hypersensitivity to any of the active or inactive ingredients of this product, known allergy to artesunate, artemisinin derived products, piperaquine, chloroquine, primaquine or any other related drugs.

Ingredients: Microcrystalline cellulose, crospovidone, Magnesium Stearate, Hydroxypropyl methylcellulose/Hypermellose, Titanium Dioxide, Polyethylene glycol/Macrogel, talc, iron oxide yellow, iron oxide red.

2.Mixed infection with another Plasmodium species at the time of presentation (including P. falciparum, P. ovale and P. malariae).

3.Severe malaria characterized by impaired consciousness, prostration, shock, acute kidney injury, convulsions, jaundice, bleeding or pulmonary edema, acidotic breathing or requiring hospitalization (as per WHO criteria) [Appendix IV].

4.Hemoglobin (Hb) level of less than 8 gm/dL or past history of hemolytic anemia, methemoglobinemia, or leukopenia due to idiosyncratic reaction to primaquine.

5.Pregnant or breast feeding women or women of child-bearing potential not willing to use medically acceptable methods of contraception throughout the study or women with positive urine pregnancy test at screening.

6.Use of concurrent medication that may induce haemolysis or haemolytic anaemia or depressants of myeloid element of the bone marrow.

7.G6PD deficiency indicated by laboratory investigation at screening.

8.Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe and/or uncontrolled disease (e.g. cardiac, renal and hepatic, CNS diseases, HIV/AIDS or other conditions which may lead to immunosuppression)

9.Any antimalarial treatment during 1 month prior to screening, as assessed by medical history or ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole.

10.Splenectomy as confirmed by history or clinical examination.

11.Electrocardiogram (ECG) abnormalities with clinical significance or relevance that require urgent management. These abnormalities include subjects with congenital prolongation of the QT interval or any other clinical condition known to prolong the QTc interval such as subjects with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease; family history of congenital prolongation of the QT interval or sudden death; known disturbance of electrolyte balance, eg., hypokalaemia or hypomagnesaemia; receiving other medications that prolong the QT interval, such as quinidine, procainamide, amiodarone, macrolide antibiotics, cisapride, terfenadine, etc; QTc interval greater than 450 msec at baseline (Day 0).

12.Known significant renal or hepatic impairment indicated by the following laboratory evaluations at screening:

�Serum creatinine greater than 1.5 times upper limit of normal (ULN)

�Aspartate transaminase greater than 2.5 times ULN

�Alanine transaminase greater 2.5 times ULN

�Serum bilirubin greater 3 mg/dL

13.Significant disease(s), disorder(s) other than malaria that in opinion of investigator may (i) put the subjects at risk because of participation in study or (ii) interfere with study evaluations (iii) cause concern regarding the subjectââ?¬•s ability to participate in the study.

14.Participat

Study & Design

• Study Type: Interventional
• Study Design: Not specified