AFRO-NETS> Invitation for studies: Giving intermittent malaria treatment

[Dieter Neuvians MD <neuvians@mweb.co.zw>]

Invitation for studies: Giving intermittent malaria treatment
-------------------------------------------------------------
Source: tdr-scientists@who.ch

Survival benefit of giving intermittent malaria treatment as a compo-
nent of the Expanded Programme of Immunization (EPI) schedule in Af-
rica

Invitation for letters of interest to participate in collaborative 
studies

WHO is inviting letters of interest from scientists interested in 
participating in collaborative studies to quantify the survival bene-
fit from intermittent malaria treatment given via EPI programmes in 
Africa.

Background

Severe anaemia in highly malarious areas is invariably a consequence 
of malaria, and is a major cause of infant death in malaria endemic 
Africa. In recent years, TDR and other partners have funded studies 
to answer the policy question of whether iron supplementation or in-
termittent malaria treatment during infancy is the better strategy 
for preventing severe anaemia, and which should be recommended, by 
the United Nations Children's Fund (UNICEF) and the World Health Or-
ganization (WHO), on a large scale in high transmission areas.

Iron supplementation has been shown to be safe and effective when 
given orally and daily during an infant's first year of life. [1] A 
recent follow up study showed that treatment with a single-dose anti-
malarial drug, sulphadoxine-pyrimethamine (SP), given to infants in 
an area of intense malaria transmission in Tanzania, reduced severe 
malarial anaemia by 50% and clinical malaria attacks by 59%. [2] In 
the study, SP was given at 2, 3 and 9 months of age as a component of 
the Expanded Programme on Immunization (EPI) vaccination schedule. 
The study was conducted in an area of Tanzania with good uptake of 
insecticide treated bednets and iron supplementation. It is hoped 
that the efficacy and safety findings from this single study will be 
confirmed by two other studies being funded by WHO/TDR and already 
under way in highly malarious countries in Africa (Ghana and Kenya). 
Roll Back Malaria, TDR, and EPI are now preparing for large-scale 
randomized controlled trials in Africa to establish the survival 
benefit of intermittent antimalarial treatment given once, 3-4 times 
a year at the routine DTP and measles vaccine contact. An infant dos-
age of an antimalarial drug is being developed by WHO for this pur-
pose.

Country selection / participation

This call for letters of interest particularly applies to UNICEF dem-
onstration countries - Senegal, Benin, Ghana and Mali. In these coun-
tries, contacts should be made with EPI programme managers and UNICEF 
programme managers for further information. The TDR secretariat will 
be pleased to assist with these communications if needed (see contact 
information below).

For a study site to qualify it would have to include a population of 
at least 1 million persons (approximating to 20,000 infants to be 
followed up) per study. The intermittent malaria treatment would need 
to be added to the existing vaccination schemes of the study sites, 
without requiring any change of those schemes, and it should be 
linked with each administration of DTP and measles vaccines (where 
immunization is provided at outreach services and at fixed outposts, 
but not through national immunization days). The effect(s) of inter-
mittent malaria treatment on immunization efficacy would be examined 
in a commissioned study that assesses interference with immunization 
response, effect on seroconversion in response to DTP and measles 
vaccine, interference of the drug(s) with the antibody assays; inter-
ference with the normal correlation of antibodies and immune protec-
tion.

Countries will be selected on the basis of:

- Mortality data in the study site on endemic Plasmodium falciparum 
  malaria

- Expected commitment to the research by the EPI programme in the 
  country; evidence will be required that appropriate officers in the 
  EPI programme have been informed and would be willing to collaborate;

- Understanding of the logistic implications of implementing such a 
  study, willingness to collaborate with other participating countries, 
  and to share results

Applications, which should be brief, need to include reference to the 
following:

- Professional details of the Principal Investigator(s) and their in-
  stitution(s). Full contact details (mail, telephone and fax), and 
  email addresses should be provided

- Confirmation of expected participation of the Ministry of Health / 
  EPI programme

- Identification and a brief description of the malaria endemic dis-
  tricts / regions to be studied

- Description of the study area and EPI programme in the study area

- Information on expected mortality from malaria in the study area, 
  obtained from hospital or other records.

Tentative timelines / schedule of activities

- Development of infant antimalarial formulation(s): September 2001 - 
  August 2002 
- Consensus meeting on proposal design, request for letters of inter-
  est: December 2001 
- Review of letters of intent - mid February 2002. Applicants will be 
  notified immediately of the outcome 
- Meeting of candidate country investigators - end February 2002 
- Early April 2002, substantive country proposals to be submitted to 
  WHO-UNICEF 
- Review of proposals and recommendation for funding - April 2002 
- Monitoring visits to candidate countries to establish feasibility 
  of studies, to assist in study preparation, identify logistic support 
  required for EPI: April-August 2002 
- July-December 2002: development and testing of mortality surveil-
  lance methods 
- December 2002: date after which study implementation can begin, 
  conditional upon feasibility and reliability of mortality surveil-
  lance methods.

How to apply

If needed, please contact Dr Melba Gomes for assistance in working 
with EPI and UNICEF programme managers, or send letters of interest 
to:

Dr Melba Gomes
Special Programme for Research and Training in Tropical Diseases (TDR)
World Health Organization
1211 Geneva 27
Switzerland
Tel: +41-22-791-3813
Fax: +41-22-791-4774
mailto:gomesm@who.int 

Applications can be sent by email, fax or mail. If applications are 
sent by fax or email followed by mail, please mark the mail copy 
"confirmation of fax/email".

Deadline for receipt of letters: 29th March 2002 (deadline extended)

For further information, please contact Dr Melba Gomes


References

1. Menendez C et al. Randomised placebo-controlled trial of iron sup-
   plementation and malaria chemoprophylaxis for prevention of severe 
   anaemia and malaria in Tanzanian infants. Lancet, 1997, 350: 844-850
   [Full text. PMID: 9310602 [PubMed - indexed for MEDLINE]]

2. Schellenberg D et al. Intermittent treatment for malaria and anae-
   mia control at time of routine vaccinations in Tanzanian infants: a 
   placebo-controlled trial. Lancet, 2001, 357 (9267): 1471-1477 [Full 
   text. PMID: 11377597 [PubMed - indexed for MEDLINE]]

Related info

- TDR Progress 1999-2000. Prevention of severe anaemia and deaths as-
  sociated with severe malaria
- Roll Back Malaria website
- Expanded Programme on Immunization Overview (World Bank)

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