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A Clinical trial to study the effect of prophylactic co-trimoxazole on mortality of under five malnourished children

A multi centered prospective twelve month, double blind, randomized placebo controlled clinical study of prophylactic Co-trimoxazole on mortality of malnourished children in two districts of INDIA (COTRIM) - COTRIM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008562
Enrollment
2200
Registered
2017-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Moderate & severe malnourished children (As per WHO criteria) aging 6 months to 4 years from Nandurbar district (Maharashtra) & Dang district (Gujarat),INDIA, those who will meet inclusion criteria. Health Condition 2: E440- Moderate protein-calorie malnutrition

Interventions

Intervention1: Co-trimoxazole dispersible tablet.: Co-trimoxazole dispersible tablet. (trimethoprim 40mg+sulphemethoxazole 200mg), once daily , orally for one year Control Intervention1: Placebo: Pla

Sponsors

Dr Babasaheb Ambedkar Vaidyakiya Pratishthan
Lead Sponsor
Bhansali Trust
Collaborator
Dr Shivaji Gunale
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Children between 6 months to 4 years classified as moderate & severe malnourished according to weight for height as per WHO criteria.

Exclusion criteria

Exclusion criteria: 1.Children with any organic disease, congenital anomaly deformity or disability. 2.Anaemia -HB less than7gm5-6 3.elevated blood glucose- blood glucose more than 140mg/dl 4.HIV positive 5.sickle cell disease (solubility test positive) ref 7 6.G-6 PD deficiency. 7.Already diagnosed sickle cell disease & thalessemia 8.history of known allergy to sulfa drugs or trimethoprim 8.Parents who are not willing for the study.

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of prophylactic Co-trimoxazole given daily in reducing mortality in malnourished childrenTimepoint: Death: Enhanced surveillance will be implemented on the study cohort to ensure that any death occurring is reported. A separate verbal autopsy form will be completed for deaths and these will be used to evaluate the causes of death.—

Secondary

MeasureTime frame
To determine effect of Co-trimoxazole prophylaxis on growth To determine effect of Co-trimoxazole prophylaxis on minor/major illnesses To determine effect of prophylactic co-trimoxazole on frequency of admission to hospitals, causes & Death.Timepoint: Growth: All study children will be followed up to evaluate changes in weight, MUAC and height at baseline & monthlyHospital admission: Rates of hospital admissions will be compared between the two groups. â?¢ Causes of readmissions and deaths: major clinical illnesses (pneumonia, gastroenteritis, sepsis etc)Toxicity: Our safety surveillance system will be set to detect and document adverse events. (Grades 3 and 4 clinical)—

Countries

India

Contacts

Public ContactDr Pratibha Phatak

Dr. Hedgewar Hospital

dranandphatak@gmail.com0240-2331195

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026