Clinical Trials

In addition to doing the surveillances and experiments in the laboratory, the department is also involved in doing clinical trials for the improvement of treatment policies, which lead to rational use of drugs and thus prevents the emergence of drug resistance.

Most of the clinical trials are multicentred, randomized, placebo controlled double blind studies, in collaboration with World Health Organization (WHO), Geneva, Johns Hopkins University, Save the Children, USA, and Boston University of USA. In all the clinical trials the patients are supported with free medicines and investigations, done either in the hospital or outside. The important completed and ongoing studies are as follows:

Topical emollient therapy for prevention of infections in preterm infants

In this study emollient sunflower oil or aquaphore was used as the physical barrier to prevent the entry of bacterial pathogens through the premature skins of pre term infants. This was a randomized double blind study conducted in Bangladesh. The study showed that the application of sunflower oil significantly reduces the incidence of nosocomial infection of newborns. The study was published in The Lancet and was a lead news in the BBC world.

Duration: 1998 - 2002
Principal Investigator: Gary L Darmstadt and Samir K Saha
Other investigators MAK Azad Chawdhury
Reference: Darmstadt GL & Saha SK Lancet 2005; 365:1039-45

Multicentre randomized clinical trial to compare the efficacy of chloramphenicol with that of amplicllin plus gentamicin in children aged 2 to 59 months with very severe pneumonia

This was a multicentre and randomized trial in collaboration with WHO, Boston University and Johns Hopkins University. The trial compared the efficacy of chloramphenicol Vs amplicllin plus gentamicin for the treatment of very severe pneumonia. The results were analyzed and submitted for publication in The Lancet.

Duration: 2000 to 2002
Principal Investigator: Samir K Saha and Mathuram Santhosam
Other investigators: Ruhul Amin, M Hanif

Efficacy of short course oral cotrimoxazole in treatment of non-severe pneumonia and its relationship with antimicrobial resistance: a clinical trial in the community of Dhaka

It was a placebo controlled 3 days Vs 5 days trial for treatment of non-severe pneumonia with cotrimoxazole in collaboration with WHO, Geneva. The patients were enrolled at the out patient department of DSH and given the treatment for 3 or 5 days. All the cases were followed up on day 3, 5 and 15 to assess the treatment failure or relapses.

The study showed no significant differences between 3 days and 5 days of treatment. However, it was found that emergence of resistance in nasopharyngeal S. pneumoniae and H. influenzae were lower in the 3 days group.

The study was presented in the WHO steering committee meeting in Geneva.

Duration: 2001 to 2002
Principal Investigator: Samir K Saha
Other investigators: Ruhul Amin, M Hanif

Follow-up of Pneumococcal meningitis cases to determine its long term impact

Pneumococcal meningitis cases were comprehensively assessed by a multidisciplinary a group for developmental and neurological status of the survived children at 30-40 days and 180-190 days of discharge.

The study showed the importance of neurodevelopmental assessment in meningitis follow up to fully unearth the burden of adverse consequences of the disease, which provides compelling economic argument for introduction of pneumococcal vaccine.

Duration: 2005-2006
Principal Investigator: Samir K Saha and Naila Z Khan
Co-investigator: Ruhul Amin and M Hanif

Comparison of 5 vs 10 days of ceftriaxone therapy for bacterial meningitis in children

This was a multicentre placebo controlled double blind study in collaboration with WHO, Geneva.
In this study, bacterial meningitis cases were given either 5 or 10 days treatment with ceftriaxone. The patients were monitored every day while in the hospital. A comprehensive follow up was given to all these cases upto 190 days, after discharge from the hospital.
The data was analyzed in July 2007.

Duration: 2002 to 2006
Principal Investigator: Samir K Saha
Other investigators: Ruhul Amin, M Hanif, Sirajul Islam, C M Haider Ali, Manzoor Hussain

Multicentre study of clinical signs predicting illness in young infant

The study was in collaboration with Save New Born Lives of Save the Children, USA, and WHO. The project aimed to validate the clinical signs in the children aged 0 to 2 months, and make an algorithm for community health workers. The children were assessed by paramedics and trained paediatricians, who were blinded to each others findings. The charts were reviewed and validated by a panel of senior paediatricians.

The data were analyzed to find the value of clinical signs, in single and in combination. The data are analyzed and the manuscript is prepared to submit in The Lancet.
Duration: 2002 to 2003

Principal Investigator: Samir K Saha and MAK Azad Chowdhury
Other Investigators: M. Monir Hossain ASM Nawshad Uddin Ahmed

Multicenter Observational Study to Assess the Safety of Outpatient Treatment of Severe Pneumonia with Oral Amoxicillin in Children aged 3 to 59 months: A pilot Study

This is an ongoing study in collaboration with WHO, Geneva. The trial is comparing the safety of out patient based oral amoxicillin therapy for severe pneumonia cases. The patients fulfilling the criteria are given oral amoxicillin and followed up at home by the trained community health workers. Any case of treatment failure are brought to the hospital and given appropriate treatment.

Duration: 2006 – 2007
Principal Investigator: Samir K Saha
Other Investigators: Salim Shakur, Ruhul Amin, M Hanif, Manzoor Hussain